Senior Director CMC Regulatory Affairs

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

Zusammenfassung

Une entreprise biopharmaceutique innovante recherche un Directeur/Snr Directeur des Affaires Réglementaires CMC pour gérer et développer des stratégies réglementaires sur plusieurs régions. Vous jouerez un rôle crucial dans l'assurance qualité des soumissions et la gestion des aspects réglementaires tout au long du cycle de vie des produits, avec un accent particulier sur la conformité avec les exigences EMA et FDA. Ce poste offre la possibilité de travail à distance depuis l'Allemagne ou la Suisse.

Qualifikationen

• Ph.D. requis en sciences pertinentes ou MSc avec expérience correspondante.
• Minimum cinq ans d'expérience en CMC réglementaire.
• Compétences excellentes en communication en anglais.

Aufgaben

• Développer et exécuter des stratégies réglementaires pour les soumissions CMC.
• Authoriser et soumettre des dossiers réglementaires en temps opportun.
• Assurer la conformité avec les exigences réglementaires globales.

Kenntnisse

Communication

Negotiation

Regulatory Expertise

Risk Mitigation

Ausbildung

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

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