**Will require relocation to Germany or remote in the United Kingdom**
Watton Hall are partnered with a leading biotech company focused on developing innovative mRNA treatments aimed at transforming patient care in various therapeutic areas. Their commitment to advancing science and improving lives drives their mission. To support these initiatives, they are actively recruiting for a Senior Director, Global Regulatory Affairs CMC, who will be responsible for guiding programs through the entire process from initial development stages up to commercialisation
Key Responsibilities
* Serve as the Global Regulatory CMC Lead, responsible for defining and implementing the regulatory strategy for Chemistry, Manufacturing, and Controls (CMC) from the clinical development phase through to market authorization.
* Plan, prepare, and conduct interactions with regulatory agencies in the field of CMC.
* Establish, modify, and continuously optimise regulatory CMC processes and interfaces (internal and external)
* Supervision of vendors in the regulatory affairs department and preparation of regulatory CMC dossiers.
Candidate Profile
* Scientific degree or any related discipline.
* Strong professional working experience in global CMC regulatory strategy leading activities.
* Have a solid understanding of the various interdisciplinary functions involved in CMC drug development, as well as how clinical research applies to both drug development and medical devices.