Senior Manager, Regulatory Affairs CMC - Oxford

TieTalent; Oxford; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Regulatory Affairs CMC to oversee critical regulatory activities in Oxford. This role involves ensuring compliance with global regulations, developing regulatory strategies, and authoring essential CMC documentation. The ideal candidate will have extensive experience in biopharmaceutical regulatory affairs, particularly in CMC, and will thrive in a dynamic, fast-paced environment. Join a team where your expertise will directly influence the success of innovative therapies and help navigate the complexities of regulatory landscapes.

Qualifications

• 5+ years in biopharmaceutical regulatory affairs, with 3+ years in a CMC lead role.
• Strong understanding of global regulatory CMC requirements.

Responsibilities

• Prepare and review CMC documentation for regulatory submissions.
• Ensure compliance with EMA, FDA, ICH, WHO regulations.
• Represent the company in Health Authority meetings.

Skills

Regulatory Affairs

CMC Documentation

Global Regulatory Compliance

Strategic Regulatory Guidance

Cross-Functional Team Leadership

Education

Undergraduate degree in a scientific discipline

Advanced degrees

Job description

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.