(Senior Director) Global Regulatory Affairs CMC

Job Opportunity: Senior Director, Global Regulatory Affairs CMC

Watton Hall is partnering with a leading biotech company dedicated to developing innovative mRNA treatments aimed at transforming patient care across various therapeutic areas. Their mission is driven by a commitment to advancing science and improving lives. To support these initiatives, they are actively recruiting for a Senior Director, Global Regulatory Affairs CMC, who will oversee programs from initial development stages through to commercialization.

Key Responsibilities

1. Serve as the Global Regulatory CMC Lead, defining and implementing regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) from clinical development to market authorization.
2. Plan, prepare, and conduct interactions with regulatory agencies concerning CMC.
3. Establish, modify, and continuously optimize regulatory CMC processes and interfaces, both internal and external.
4. Supervise vendors within the regulatory affairs department and oversee the preparation of regulatory CMC dossiers.

Candidate Profile

• Possess a scientific degree or related discipline.
• Have strong professional experience in leading global CMC regulatory strategies.
• Possess a solid understanding of interdisciplinary functions involved in CMC drug development, including the application of clinical research to both drug development and medical devices.

Note: The role requires relocation to Germany or remote work in the United Kingdom.