Associate Director, Regulatory Affairs CMC

AL Solutions; United Kingdom; Remote; GBP 80,000 - 120,000; Full time

Job summary

A leading consultancy is seeking an Associate Director in Regulatory Affairs CMC to lead regulatory strategies for biologics and advanced therapies. This fully remote role offers significant influence across multiple programs, exposure to global regulatory frameworks, and opportunities for career growth in a fast-paced environment.

Benefits

Flexible work environment

Career growth opportunities

Exposure to top-tier clients

Qualifications

• 8–12 years in CMC Regulatory Affairs with expertise in biologics.
• Experience leading global submissions across product lifecycle.
• Strong scientific knowledge of drug development and quality systems.

Responsibilities

• Develop and implement CMC regulatory strategies for biologics.
• Act as primary regulatory contact for client projects.
• Manage preparation and submission of regulatory documents.

Skills

Communication

Stakeholder Management

Scientific Knowledge

Job description

Associate Director, Regulatory Affairs CMC

This role is with AL Solutions, a company connecting top Regulatory Affairs & C-suite talent with Biotech, CRO, and Pharmaceutical clients across Europe and the US. The position is fully remote and involves leading regulatory strategy for biologic and advanced therapy programs.

Key Responsibilities:

• Develop and implement CMC regulatory strategies for biologics during development and post-approval
• Act as the primary regulatory contact for client projects and interactions with Health Authorities
• Manage preparation, review, and submission of INDs, IMPDs, BLAs, MAAs, variations, and supplements
• Contribute to regulatory intelligence and advise teams on regulatory expectations
• Support client engagements, proposals, and consultations
• Mentor junior team members on CMC matters

Your Profile:

• 8–12 years in CMC Regulatory Affairs, with expertise in biologics (e.g., mAbs, cell/gene therapy, ATMPs)
• Experience leading global submissions across product lifecycle
• Strong scientific knowledge of drug development, manufacturing, and quality systems
• Experience in consultancy, CRO, or agile biotech preferred
• Excellent communication and stakeholder management skills
• EU-based or relevant global experience

What’s On Offer:

• Strategic Associate Director role with influence across multiple programs
• Fully remote and flexible work environment
• Exposure to biologics and global regulatory frameworks
• Career growth in a fast-paced consultancy
• Work with top-tier clients in EU and US markets

Additional Details:

• Seniority level: Director
• Employment type: Full-time
• Job function: Research
• Industries: Research Services, Pharmaceutical Manufacturing, Biotechnology