Associate Director, Regulatory Affairs CMC

JR United Kingdom; Lincoln; Remote; GBP 80,000 - 100,000; Full time

Job summary

A fast-growing life sciences consultancy seeks an Associate Director of Regulatory Affairs – CMC for a fully remote role. The position involves leading regulatory strategy and execution for biologic and therapy programs while interacting directly with biotech clients and guiding CMC-related projects. This role requires extensive experience and promises strategic influence within an innovative environment.

Benefits

Fully remote, flexible working environment

Career progression in a collaborative consultancy

Exposure to cutting-edge biologics and regulatory frameworks

Qualifications

• 8–12 years of experience in CMC Regulatory Affairs, with strong biologics expertise.
• Proven track record leading global submissions across the product lifecycle.
• Previous experience in a consultancy or CRO is highly desirable.

Responsibilities

• Lead the development and implementation of CMC regulatory strategies.
• Serve as the primary regulatory point of contact for client projects.
• Oversee preparation, review, and submission of INDs and MAAs.

Skills

Client-facing interactions

Stakeholder management

Communication

Scientific understanding of drug development

Regulatory intelligence

Job description

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Associate Director, Regulatory Affairs CMC, lincoln

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Client:

AL Solutions

Location:

lincoln, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

Posted:

06.06.2025

Expiry Date:

21.07.2025

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Job Description:

A fast-growing and forward-thinking life sciences consultancy is seeking an Associate Director of Regulatory Affairs – CMC to lead regulatory strategy and execution across a dynamic portfolio of biologic and advanced therapy programs. This fully remote opportunity is ideal for an experienced, client-facing regulatory professional ready to make a broader strategic impact.

As an Associate Director, you will work directly with biotech clients across early- and late-stage development, taking the lead on CMC regulatory activities and guiding project teams through global regulatory pathways.

Key Responsibilities:

• Lead the development and implementation of CMC regulatory strategies for biologics across development and post-approval stages
• Serve as the primary regulatory point of contact for client projects and Health Authority interactions
• Oversee preparation, review, and submission of INDs, IMPDs, BLAs, MAAs, variations, and supplements
• Contribute to internal regulatory intelligence and advise cross-functional teams on evolving regulatory expectations
• Support strategic client engagements, including proposal development and consultation meetings
• Mentor and guide junior regulatory team members on CMC-related matters

Your Profile:

• 8–12 years of experience in CMC Regulatory Affairs, with strong biologics expertise (e.g. mAbs, cell/gene therapy, ATMPs)
• Proven track record leading global submissions across the product lifecycle
• Strong scientific understanding of drug development, manufacturing, and quality systems
• Previous experience in a consultancy, CRO, or agile biotech environment is highly desirable
• Excellent communication and stakeholder management skills, including client-facing interactions
• EU-based preferred, but global applicants with relevant experience will be considered

What’s On Offer:

• Associate Director-level role with strategic influence across multiple client programs
• Fully remote, flexible working environment
• Exposure to cutting-edge biologics and global regulatory frameworks
• Career progression in a collaborative, fast-paced consultancy
• Opportunity to work with top-tier clients across the EU and US markets