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 managementAuthor, review, approve and submit regulatory filings in a timely mannerProvide 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 authoritiesEnsure 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 timelinesQualifications :Ph.D, in Chemistry, Biopharmaceuticals, Biochemistry, Biology or MSc with relevant experience.At least five years in Regulatory CMCExperience with regulatory CMC filings (IND / IMPD, BLA / NDA / MAA).Experience with CMC submissions with ADCs or Biologics and Small MoleculesMust have experience with CMC filing in the Oncology fieldExcellent communication and negotiation skills in English.Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercialThis role can be remote in either Germany or Switzerland #J-18808-Ljbffr