Associate Director Regulatory CMC

  • Location

  • Salary

  • Job Type

  • Functions

    Regulatory Affairs

Your Responsibilities

Provide regulatory affairs CMC strategy guidance to support integrated projects throughout the entire development lifecycle.

Lead and drive global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects, namely INDs/BLAs/MAAs applications including scientific and technical review for accuracy, soundness, and regulatory appropriateness.

Act as liaison with local health authority to apply, maintain, and update Manufacturing and Importation Authorization licenses for each site in Germany, to ensure compliance with all applicable regulatory requirements.

Act as EU regulatory SME via participation in RA regulatory compliance activities, e.g., participate in RA international Newsletter group; participate in cross-function gap identification for emerging new regulatory trend and guidance; Provide Quarterly company-wide regulatory gap analysis status updates; Lead cross-function review process to provide comments for draft guidance.

Represents Regulatory CMC on cross-functional project teams of both internal and external ones. In this capacity, the Associate Director/Director is the point of contact on critical regulatory activities for the project.

Develop and maintain professional partnerships with both internal and external stakeholders.

Initiate and lead project team activities related to Health Authority interactions and negotiations: setting objectives, preparing briefing books, coordinating, and planning rehearsals and risk mitigation plans.

Provide strategic advice and direction to junior staff within the department for assigned projects. Oversees planning and execution of global regulatory activities and submissions. Ensure development of robust global regulatory strategies for the projects.

Accountable for providing regulatory assessments of new business opportunities as required.

Your Profile
The ideal candidate for this position will have the following:
* B.Sc. or BA in Life Science (Chemistry, pharmacy, biology, chemical engineering, or a related pharmaceutical science). Master or advanced degree preferred.
* 7-10 years pharmaceutical industry experience in R&D, Regulatory CMC, or related functions, with at least 5 years working in regulatory affairs CMC.
* Extensive knowledge of regulatory requirements for biologics in the EU, and Germany’s local regulatory requirements for drug manufacturing.
* Experience with at least one major marketing application (NDA/BLA/MAA/JNDA etc.), or extensive experience with late-stage development/marketed products.
* Experience with RA CMC vaccine and or biologics is desired.
* Fluent English and German language skills

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