Senior Director CMC Regulatory Affairs

BioTalent; Stuttgart; Remote; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

A clinical stage biotech company is seeking a Director/Snr Director of Regulatory Affairs CMC to develop and implement regulatory strategies for CMC submissions. The ideal candidate will have a Ph.D. or MSc with significant experience in Regulatory CMC, particularly in Oncology, and will play a crucial role in ensuring compliance with regulatory standards while collaborating closely with senior management.

Qualifikationen

• At least five years in Regulatory CMC.
• Experience with regulatory filings (IND / IMPD, BLA / NDA / MAA).
• Must have experience with CMC filing in the Oncology field.

Aufgaben

• Develop and execute regulatory strategies for CMC components.
• Author, review, and submit regulatory filings in a timely manner.
• Ensure compliance with global regulatory requirements (EMA, FDA, ICH).

Kenntnisse

Regulatory CMC

Communication

Negotiation

Ausbildung

Ph.D. in Chemistry, Biopharmaceuticals, Biochemistry, Biology

MSc with relevant experience

Jobbeschreibung

Our client are a clinical stage biotech company pioneering in the ADC space. They recently completed an oversubscribed financing round and innovating in the IO space. They have recently entered Phase 1 and now looking a Director / Snr Director of Regulatory Affairs CMC.

Position Overview :

• Develop and execute regulatory strategies for the CMC components of regulatory submissions.
• Support initial applications, annual updates, clinical trials, BLAs and manage the regulatory aspects of the product lifecycle in close collaboration with the regulatory department and senior management
• Author, review, approve and submit regulatory filings in a timely manner
• Provide regulatory expertise on CMC issues and work closely with GMP area leads to define stage appropriate development strategies anticipating regulatory concerns (risk mitigation) or in response to questions / requests from regulatory authorities
• Ensure preparation of high-quality regulatory documentation for CMC-related topics and filings. And lead the review and submission of these documents.
• Ensure compliance with applicable global regulatory requirements (EMA, FDA, ICH guidelines, …)
• Provide senior leadership with regulatory input related to product development strategy and timelines

Qualifications :

• Ph.D, in Chemistry, Biopharmaceuticals, Biochemistry, Biology or MSc with relevant experience.
• At least five years in Regulatory CMC
• Experience with regulatory CMC filings (IND / IMPD, BLA / NDA / MAA).
• Experience with CMC submissions with ADCs or Biologics and Small Molecules
• Must have experience with CMC filing in the Oncology field
• Excellent communication and negotiation skills in English.
• Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial
• This role can be remote in either Germany or Switzerland