Associate Director Regulatory Compliance

4 days ago

United Kingdom Advanced Resource Managers Full time

Associate Director Regulatory Affairs - CMC
Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is 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.

You will provide innovative solutions including global regulatory therapeutic area expertise, strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization although the team have a preference for someone to have strong post-approval experience over pre-approval.

You will be leading 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 role is a permanent full time position and will offer a competitive salary alongside an extensive benefits package.

patel@arm-talent.

  • Associate Director Regulatory Compliance

    4 days ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is 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. You will provide innovative...

  • Associate Director Regulatory

    4 days ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is 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. You will provide innovative...

  • Associate Director Regulatory

    4 days ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is 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. You will provide innovative...

  • Associate Director Regulatory Affairs

    1 day ago

    united kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is 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. You will provide innovative...

  • Associate Director Regulatory

    4 days ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMCAdvanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is 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.You will provide innovative...

  • Associate Director Regulatory

    3 days ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMCAdvanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is 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.You will provide innovative...

  • Associate Director Regulatory

    3 days ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is 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. You will provide innovative...

  • Compliance Director

    1 week ago

    United Kingdom Compliance Professionals Full time

    Our client is an international banking organization, looking to hire a Compliance Manager for their London branch. The firm mainly specializes in Personal and Corporate Banking. Assist with the building, design and update of regulatory compliance policies and procedures to minimise regulatory risk. Support business relationships through positive...

  • Compliance Director

    1 week ago

    United Kingdom Compliance Professionals Full time

    Our client is an international banking organization, looking to hire a Compliance Manager for their London branch. The firm mainly specializes in Personal and Corporate Banking. Assist with the building, design and update of regulatory compliance policies and procedures to minimise regulatory risk. Support business relationships through positive...

  • Compliance Director

    3 weeks ago

    United Kingdom Compliance Professionals Full time

    Our global is a global fintech banking group who are looking for a Compliance Manager to join the London business. Lead regulatory horizon scanning and provide risk-based analysis to guide Bank’s strategic decisions. Drive regulatory change projects and deliver clear progress reporting to senior management. Champion the bank’s approach to...

  • Compliance Director

    3 weeks ago

    United Kingdom Compliance Professionals Full time

    Our global is a global fintech banking group who are looking for a Compliance Manager to join the London business. Lead regulatory horizon scanning and provide risk-based analysis to guide Bank’s strategic decisions. Drive regulatory change projects and deliver clear progress reporting to senior management. Champion the bank’s approach to...

  • Director of Regulatory Compliance

    4 weeks ago

    United Kingdom EPM Scientific Full time

    ABOUT THE ROLE The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. Provide high level strategic and operational regulatory direction and mentorship on projects...

  • Director of Regulatory Compliance

    3 weeks ago

    United Kingdom EPM Scientific Full time

    ABOUT THE ROLE The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. Provide high level strategic and operational regulatory direction and mentorship on projects...

  • Regulatory Support Officer

    1 week ago

    United Kingdom VRS Regulatory Full time

    A rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business: Work under the supervision of an experienced regulatory manager Provide regulatory support to a wide range of chemical products Ongoing and comprehensive training. An excellent opportunity to start and establish your career...

  • Regulatory Support Officer

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    A rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business: Work under the supervision of an experienced regulatory manager Provide regulatory support to a wide range of chemical products Ongoing and comprehensive training. An excellent opportunity to start and establish your career...

  • Regulatory Support Officer

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    A rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive training. An excellent opportunity to start and establish your career in...

  • Regulatory Support Officer

    1 day ago

    united kingdom VRS Regulatory Full time

    A rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business: Work under the supervision of an experienced regulatory manager Provide regulatory support to a wide range of chemical products Ongoing and comprehensive training. An excellent opportunity to start and establish your career in...

  • Regulatory Support Officer

    1 week ago

    United Kingdom VRS Regulatory Full time

    A rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business: Work under the supervision of an experienced regulatory manager Provide regulatory support to a wide range of chemical products Ongoing and comprehensive training. An excellent opportunity to start and establish your career in...

  • Regulatory Support Officer

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    A rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive training. An excellent opportunity to start and establish your career in...

  • Regulatory Affairs

    24 hours ago

    United Kingdom Coopman Search and Selection | B Corp™ Full time

    Coopman Search and Selection are currently partnered with one of the most exciting global hedge funds who are looking to hire a Compliance Officer. The role will report in directly into the Compliance Director and form part of a larger team. In this role you will be acting as the primary contact for any US Compliance regulatory matters, this position,...