Director Global Regulatory Cmc Authoring

Proclinical is seeking a Director for Global Regulatory Affairs CMC. The successful candidate will be responsible for authoring global quality regulatory documentation for multiple medium-complexity projects. The role also involves defining and establishing platform approaches to the preparation of quality regulatory documentation used in development, registration, and post-approval stages.

Key Responsibilities:

• Author global quality regulatory documentation for multiple medium-complexity projects in a timely manner and according to relevant procedures.
• Define and establish platform approaches to the preparation of quality regulatory documentation.
• Support alignment of structure and contents of quality regulatory documentation across company platforms.
• Contribute significantly to the development of regulatory CMC strategy for assigned projects.
• Liaise with relevant stakeholders to facilitate the preparation of quality regulatory documentation.

Requirements:

• Degree in biochemistry, pharmacy or another related field.
• Proven experience in regulatory affairs focusing on Biologics, Vaccines.
• Extensive experience in authoring regulatory CMC documents for clinical trial applications and/or marketing authorisations.
• Solid knowledge of product life cycle management and understanding of scientific principles and regulatory CMC requirements relevant to global drug development.
• Excellent communication skills in English (written and spoken).
• Organisational talent, analytical and conceptual skills.

Apply Now:
If you are having difficulty in applying or if you have any questions, please contact Jaeme Pawl at J.pawl@proclinical.com

About Proclinical:
Proclinical is a leading recruiter in the life sciences sector, dedicated to pairing exceptional talent with top positions globally. Want to stay updated? Follow us and check out our website for live roles and updates www.proclinical.com