Company Overview:
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