Regulatory Affairs Director
Vor 4 Tagen
Advanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to join our client, a leading Biotech business through a CRO. This role will be solely working with one of their main partners, focusing on driving and leading regulatory CMC strategy.
Key Responsibilities:
- Provide innovative solutions, including global regulatory therapeutic area expertise, strategic regulatory intelligence, and guidance for product development from preclinical through registration and product optimization.
- Lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.
- Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the EMA and regional agencies.
- Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAA and variations.
Post-Approval Compliance and Life Cycle Management:
- Lead the CMC regulatory management and submission planning of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products.
- Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals.
This is a permanent full-time position offering a competitive salary and an extensive benefits package.
-
Regulatory Affairs Director
vor 2 Wochen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs Career Opportunity **About the Role** Advanced Resource Managers is seeking a highly skilled Regulatory Affairs professional to join our team in Germany. As an Associate Director of Regulatory Affairs, you will play a key role in preparing regulatory compliance review packages for our clinical team. **Key Responsibilities** •...
-
Regulatory Affairs Director
vor 2 Wochen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs Career Opportunity **About the Role** Advanced Resource Managers is seeking a highly skilled Regulatory Affairs professional to join our team in Germany. As an Associate Director of Regulatory Affairs, you will play a key role in preparing regulatory compliance review packages for our clinical team. **Key Responsibilities** •...
-
Regulatory Affairs Director
Vor 4 Tagen
Deutschland Advanced Resource Managers VollzeitAdvanced Resource Managers is seeking a highly skilled Associate Director of Regulatory Affairs to join their clinical submission team in Germany. The ideal candidate will have a strong background in regulatory compliance and experience working with clinical teams to prepare regulatory review packages. Key responsibilities include: * Collaborating with the...
-
Regulatory Affairs Director
Vor 4 Tagen
Deutschland Advanced Resource Managers VollzeitAdvanced Resource Managers is seeking a highly skilled Associate Director of Regulatory Affairs to join their clinical submission team in Germany. The ideal candidate will have a strong background in regulatory compliance and experience working with clinical teams to prepare regulatory review packages. Key responsibilities include: * Collaborating with the...
-
Regulatory Affairs Director
Vor 4 Tagen
Deutschland Advanced Resource Managers VollzeitAssociate Director Regulatory Affairs - CMCAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to join our client, a leading Biotech business through a CRO. This role will be solely working with one of their main partners, focusing on driving and leading regulatory CMC strategy.Key Responsibilities:Provide...
-
Regulatory Affairs Director
Vor 4 Tagen
Deutschland Advanced Resource Managers VollzeitAssociate Director Regulatory Affairs - CMCAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to join our client, a leading Biotech business through a CRO. This role will be solely working with one of their main partners, focusing on driving and leading regulatory CMC strategy.Key Responsibilities:Provide...
-
Regulatory Affairs Director
Vor 4 Tagen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs Director OpportunityAdvanced Resource Managers is seeking an experienced Regulatory Affairs Director to join our team in Germany. As a key member of our clinical submission team, you will be responsible for preparing, reviewing, and coordinating regulatory submissions under the new EU CTR process.Main Responsibilities:Provide guidance on...
-
Regulatory Affairs Director
Vor 4 Tagen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs Director OpportunityAdvanced Resource Managers is seeking an experienced Regulatory Affairs Director to join our team in Germany. As a key member of our clinical submission team, you will be responsible for preparing, reviewing, and coordinating regulatory submissions under the new EU CTR process.Main Responsibilities:Provide guidance on...
-
Regulatory Affairs Director
vor 2 Wochen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs - CMC **About the Role** Advanced Resource Managers is seeking an experienced Associate Director to lead our client's regulatory affairs efforts in the EMEA region. As a key member of the team, you will be responsible for developing and executing CMC regulatory strategies for biological products. **Key Responsibilities** * Provide...
-
Regulatory Affairs Director
vor 2 Wochen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs - CMC **About the Role** Advanced Resource Managers is seeking an experienced Associate Director to lead our client's regulatory affairs efforts in the EMEA region. As a key member of the team, you will be responsible for developing and executing CMC regulatory strategies for biological products. **Key Responsibilities** * Provide...
-
Regulatory Affairs Director
vor 2 Wochen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs - CMC **About the Role** Advanced Resource Managers is seeking an experienced Regulatory Affairs Director to lead the development and execution of CMC regulatory strategies for biological products in the EMEA region. As a key member of our team, you will provide innovative solutions and strategic regulatory intelligence to drive product...
-
Regulatory Affairs Director
vor 2 Wochen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs - CMC **About the Role** Advanced Resource Managers is seeking an experienced Regulatory Affairs Director to lead the development and execution of CMC regulatory strategies for biological products in the EMEA region. As a key member of our team, you will provide innovative solutions and strategic regulatory intelligence to drive product...
-
Associate Director Regulatory Affairs
vor 1 Woche
Deutschland Advanced Resource Managers VollzeitAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs to join their clinical submission team in Germany. The successful candidate will work closely with the clinical team to prepare regulatory compliance review packages. Key responsibilities include: * Bachelor's degree * Basic medical/therapeutic area and medical...
-
Associate Director Regulatory Affairs
vor 1 Woche
Deutschland Advanced Resource Managers VollzeitAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs to join their clinical submission team in Germany. The successful candidate will work closely with the clinical team to prepare regulatory compliance review packages. Key responsibilities include: * Bachelor's degree * Basic medical/therapeutic area and medical...
-
Associate Director Regulatory Affairs
Vor 6 Tagen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs Director - CMC StrategyAdvanced Resource Managers is seeking an experienced Regulatory Affairs Director to lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.Key Responsibilities:Provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory...
-
Associate Director Regulatory Affairs
Vor 6 Tagen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs Director - CMC StrategyAdvanced Resource Managers is seeking an experienced Regulatory Affairs Director to lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.Key Responsibilities:Provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory...
-
Associate Director Regulatory Affairs
Vor 6 Tagen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs Director - CMC StrategyAdvanced Resource Managers is seeking an experienced Regulatory Affairs Director to lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.Key Responsibilities:Provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory...
-
Associate Director Regulatory Affairs
Vor 6 Tagen
Deutschland Advanced Resource Managers VollzeitRegulatory Affairs Director - CMC StrategyAdvanced Resource Managers is seeking an experienced Regulatory Affairs Director to lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.Key Responsibilities:Provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory...
-
Associate Director Regulatory Affairs
vor 2 Wochen
Deutschland Advanced Resource Managers VollzeitAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs to join their clinical submission team in Germany. The successful candidate will work closely with the clinical team to prepare regulatory compliance review packages. Key responsibilities include: * Bachelor's degree * Basic medical/therapeutic area and medical...
-
Associate Director Regulatory Affairs
vor 2 Wochen
Deutschland Advanced Resource Managers VollzeitAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs to join their clinical submission team in Germany. The successful candidate will work closely with the clinical team to prepare regulatory compliance review packages. Key responsibilities include: * Bachelor's degree * Basic medical/therapeutic area and medical...