5 okt 2020
Sr Manager CMC-Regulatory Affairs
| Branche | Zie onder |
| Dienstverband | Uitzenden en detacheren |
| Uren | 32 - 40 uur |
| Locatie | Leiden |
| Salarisindicaties | 0-5.000 |
| Opleidingsniveau | HBO / bachelor |
| Organisatie | Modis |
| Contactpersoon |
Cindy van Gorp - Guldenaar 06-12781269 |
Informatie
Bedrijfsomschrijving
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Organisational Context
You will report to the Director RA CMC. You will be interacting with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. You will have an SME role in health authority meetings. You will be working on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Functieprofiel
You will be working in the Regulatory Affairs Department, in the Biologicals Team that is represented in Leiden, US and Japan, and play a key role in the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions for Biologicals, including cell therapies (monoclonal antibodies). This includes licence applications, post-approval projects and variations.
In this position you will be responsible for development and successful execution of CMC regulatory strategy (e.g., CMC strategy/planning for NMEs and NBEs) in close collaboration with Global Regulatory Lead, and writing of CMC
You will be asked to act as the subject matter expert (SME) for Regulatory CMC and work in close collaboration with stakeholders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners).
Specific responsibilities include
• Independently acts as CMC regulatory lead or Deputy for complex projects/products and/or participates in non-product or overarching related activities.
• Prepares and reviews with minimal supervision, CMC documentation of e-CTD Quality modules, IND/CTA/IB and briefing documents for Health Authority (HA) consultation meeting for assigned products.
• Acts as CMC regulatory expert by global project and product teams/task forces and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions.
• Member of global project teams/task forces which require expert interpretation of applicable EMA/FDA/PMDA/ICH/Global regulations to ensure CMC compliance within the organization.
• Provides CMC regulatory expertise for New Product Planning and Licensing due diligence activities.
• Manages the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with local and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global Health Authorities.
• Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.
• Defines and implements regulatory strategies and priorities for; global and regional registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control processes and related compliance issues in collaboration with local, regional and global stakeholders.
• Oversees submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs.
• Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.
Bedrijfsprofiel
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Organisational Context
You will report to the Director RA CMC. You will be interacting with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. You will have an SME role in health authority meetings. You will be working on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Functie-eisenWe are looking for candidates with the following skill set:
• You have at least a BSc in Chemistry/Pharmaceutics, Medical or equivalent degree and 8+ years industry experience; pharma, CRO or academic with at least 3 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities in CMC related laboratories and experience with Biologicals
• An additional experience next to small molecules, such as biological, vaccines, cell therapy or (medical) devices in a regulatory environment, or vice versa, might be a preference.
• Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
• Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
• Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance is an advantage;
• Demonstrated track record for successful interactions with (global) health authorities related to CMC submissions.
• Effective writing skills with the ability to meet regulatory requirements and standards
• Ability to understand regulatory environment and apply concepts
Furthermore:
You have strong interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment as well as the ability to work in a cross-functional international environment.
You are able to manage complex projects by exercising independent decision making and analytical thinking skills
Offer
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
Connect Smarter.
More information
If you wish to receive more information first, please contact us on technologylifescience@modis.com or 040 - 7999 010
I want to apply now
Please tell us who you are and what motivates you! Send us your using the application button on this website.
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Organisational Context
You will report to the Director RA CMC. You will be interacting with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. You will have an SME role in health authority meetings. You will be working on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Functieomschrijving
Functieprofiel
You will be working in the Regulatory Affairs Department, in the Biologicals Team that is represented in Leiden, US and Japan, and play a key role in the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions for Biologicals, including cell therapies (monoclonal antibodies). This includes licence applications, post-approval projects and variations.
In this position you will be responsible for development and successful execution of CMC regulatory strategy (e.g., CMC strategy/planning for NMEs and NBEs) in close collaboration with Global Regulatory Lead, and writing of CMC
You will be asked to act as the subject matter expert (SME) for Regulatory CMC and work in close collaboration with stakeholders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners).
Specific responsibilities include
• Independently acts as CMC regulatory lead or Deputy for complex projects/products and/or participates in non-product or overarching related activities.
• Prepares and reviews with minimal supervision, CMC documentation of e-CTD Quality modules, IND/CTA/IB and briefing documents for Health Authority (HA) consultation meeting for assigned products.
• Acts as CMC regulatory expert by global project and product teams/task forces and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions.
• Member of global project teams/task forces which require expert interpretation of applicable EMA/FDA/PMDA/ICH/Global regulations to ensure CMC compliance within the organization.
• Provides CMC regulatory expertise for New Product Planning and Licensing due diligence activities.
• Manages the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with local and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global Health Authorities.
• Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.
• Defines and implements regulatory strategies and priorities for; global and regional registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control processes and related compliance issues in collaboration with local, regional and global stakeholders.
• Oversees submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs.
• Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.
Bedrijfsprofiel
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Organisational Context
You will report to the Director RA CMC. You will be interacting with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. You will have an SME role in health authority meetings. You will be working on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Functie-eisenWe are looking for candidates with the following skill set:
• You have at least a BSc in Chemistry/Pharmaceutics, Medical or equivalent degree and 8+ years industry experience; pharma, CRO or academic with at least 3 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities in CMC related laboratories and experience with Biologicals
• An additional experience next to small molecules, such as biological, vaccines, cell therapy or (medical) devices in a regulatory environment, or vice versa, might be a preference.
• Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
• Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
• Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance is an advantage;
• Demonstrated track record for successful interactions with (global) health authorities related to CMC submissions.
• Effective writing skills with the ability to meet regulatory requirements and standards
• Ability to understand regulatory environment and apply concepts
Furthermore:
You have strong interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment as well as the ability to work in a cross-functional international environment.
You are able to manage complex projects by exercising independent decision making and analytical thinking skills
Offer
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
Connect Smarter.
More information
If you wish to receive more information first, please contact us on technologylifescience@modis.com or 040 - 7999 010
I want to apply now
Please tell us who you are and what motivates you! Send us your using the application button on this website.
Omschrijving
Bedrijfsomschrijving
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Organisational Context
You will report to the Director RA CMC. You will be interacting with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. You will have an SME role in health authority meetings. You will be working on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Functieprofiel
You will be working in the Regulatory Affairs Department, in the Biologicals Team that is represented in Leiden, US and Japan, and play a key role in the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions for Biologicals, including cell therapies (monoclonal antibodies). This includes licence applications, post-approval projects and variations.
In this position you will be responsible for development and successful execution of CMC regulatory strategy (e.g., CMC strategy/planning for NMEs and NBEs) in close collaboration with Global Regulatory Lead, and writing of CMC
You will be asked to act as the subject matter expert (SME) for Regulatory CMC and work in close collaboration with stakeholders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners).
Specific responsibilities include
• Independently acts as CMC regulatory lead or Deputy for complex projects/products and/or participates in non-product or overarching related activities.
• Prepares and reviews with minimal supervision, CMC documentation of e-CTD Quality modules, IND/CTA/IB and briefing documents for Health Authority (HA) consultation meeting for assigned products.
• Acts as CMC regulatory expert by global project and product teams/task forces and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions.
• Member of global project teams/task forces which require expert interpretation of applicable EMA/FDA/PMDA/ICH/Global regulations to ensure CMC compliance within the organization.
• Provides CMC regulatory expertise for New Product Planning and Licensing due diligence activities.
• Manages the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with local and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global Health Authorities.
• Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.
• Defines and implements regulatory strategies and priorities for; global and regional registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control processes and related compliance issues in collaboration with local, regional and global stakeholders.
• Oversees submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs.
• Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.
Bedrijfsprofiel
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Organisational Context
You will report to the Director RA CMC. You will be interacting with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. You will have an SME role in health authority meetings. You will be working on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Functie-eisenWe are looking for candidates with the following skill set:
• You have at least a BSc in Chemistry/Pharmaceutics, Medical or equivalent degree and 8+ years industry experience; pharma, CRO or academic with at least 3 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities in CMC related laboratories and experience with Biologicals
• An additional experience next to small molecules, such as biological, vaccines, cell therapy or (medical) devices in a regulatory environment, or vice versa, might be a preference.
• Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
• Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
• Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance is an advantage;
• Demonstrated track record for successful interactions with (global) health authorities related to CMC submissions.
• Effective writing skills with the ability to meet regulatory requirements and standards
• Ability to understand regulatory environment and apply concepts
Furthermore:
You have strong interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment as well as the ability to work in a cross-functional international environment.
You are able to manage complex projects by exercising independent decision making and analytical thinking skills
Offer
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
Connect Smarter.
More information
If you wish to receive more information first, please contact us on technologylifescience@modis.com or 040 - 7999 010
I want to apply now
Please tell us who you are and what motivates you! Send us your using the application button on this website.
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Organisational Context
You will report to the Director RA CMC. You will be interacting with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. You will have an SME role in health authority meetings. You will be working on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Functieomschrijving
Functieprofiel
You will be working in the Regulatory Affairs Department, in the Biologicals Team that is represented in Leiden, US and Japan, and play a key role in the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions for Biologicals, including cell therapies (monoclonal antibodies). This includes licence applications, post-approval projects and variations.
In this position you will be responsible for development and successful execution of CMC regulatory strategy (e.g., CMC strategy/planning for NMEs and NBEs) in close collaboration with Global Regulatory Lead, and writing of CMC
You will be asked to act as the subject matter expert (SME) for Regulatory CMC and work in close collaboration with stakeholders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners).
Specific responsibilities include
• Independently acts as CMC regulatory lead or Deputy for complex projects/products and/or participates in non-product or overarching related activities.
• Prepares and reviews with minimal supervision, CMC documentation of e-CTD Quality modules, IND/CTA/IB and briefing documents for Health Authority (HA) consultation meeting for assigned products.
• Acts as CMC regulatory expert by global project and product teams/task forces and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions.
• Member of global project teams/task forces which require expert interpretation of applicable EMA/FDA/PMDA/ICH/Global regulations to ensure CMC compliance within the organization.
• Provides CMC regulatory expertise for New Product Planning and Licensing due diligence activities.
• Manages the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with local and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global Health Authorities.
• Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.
• Defines and implements regulatory strategies and priorities for; global and regional registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control processes and related compliance issues in collaboration with local, regional and global stakeholders.
• Oversees submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs.
• Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.
Bedrijfsprofiel
Our client is an international pharmaceutical company with two sites in the Netherlands. The Leiden site is mainly responsible for Pharmacovigilance, Regulatory and Medical activities.
Organisational Context
You will report to the Director RA CMC. You will be interacting with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. You will have an SME role in health authority meetings. You will be working on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Functie-eisenWe are looking for candidates with the following skill set:
• You have at least a BSc in Chemistry/Pharmaceutics, Medical or equivalent degree and 8+ years industry experience; pharma, CRO or academic with at least 3 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities in CMC related laboratories and experience with Biologicals
• An additional experience next to small molecules, such as biological, vaccines, cell therapy or (medical) devices in a regulatory environment, or vice versa, might be a preference.
• Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
• Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
• Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance is an advantage;
• Demonstrated track record for successful interactions with (global) health authorities related to CMC submissions.
• Effective writing skills with the ability to meet regulatory requirements and standards
• Ability to understand regulatory environment and apply concepts
Furthermore:
You have strong interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment as well as the ability to work in a cross-functional international environment.
You are able to manage complex projects by exercising independent decision making and analytical thinking skills
Offer
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
Connect Smarter.
More information
If you wish to receive more information first, please contact us on technologylifescience@modis.com or 040 - 7999 010
I want to apply now
Please tell us who you are and what motivates you! Send us your using the application button on this website.
