Senior Manager, Regulatory Affairs CMC - Oxford
This role at Immunocore involves managing multiple Regulatory CMC activities, including communication with international Health Authorities, ensuring compliance with global regulatory requirements, and developing regulatory strategies. The position requires authoring, developing, and maintaining regulatory CMC dossiers, and working closely with various teams throughout clinical development and commercial lifecycle.
Key Responsibilities include:
1. Preparing and reviewing CMC documentation for regulatory submissions across various phases of development and post-approval activities.
2. Ensuring compliance with EMA, FDA, ICH, WHO, and other global regulations.
3. Managing the preparation of Module 2 and Module 3 documents following CTD guidelines.
4. Representing Immunocore in Health Authority meetings and leading CMC-related discussions.
5. Maintaining relationships with regulatory colleagues and Health Authorities.
6. Staying updated on evolving regulatory requirements and sharing knowledge with team members.
7. Evaluating business opportunities and change proposals for regulatory impact.
8. Planning and preparing CMC submissions for INDs, BLAs, MAAs, and NDS.
Minimum Requirements:
* At least 5 years of experience in biopharmaceutical regulatory affairs, with a minimum of 3 years in a CMC lead role.
* Undergraduate degree in a scientific discipline; advanced degrees are a plus.
* Strong understanding of scientific principles and global regulatory CMC requirements.
* Experience providing strategic regulatory guidance in drug development.
* Ability to work within a matrix environment and motivate cross-functional teams.
* Flexibility and comfort with ambiguity in a fast-paced setting.
Preferred experience includes managing Module 3/IMPDS submissions, conducting Health Authority meetings, and maintaining ongoing relationships with global agencies. The role is based in Oxford, England, and requires proficiency in English.
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