Associate Director, Regulatory Affairs CMC

JR United Kingdom; Chelmsford; Remote; GBP 80,000 - 120,000; Full time

Job summary

Une entreprise de conseil en sciences de la vie recherche un Associate Director en affaires réglementaires – CMC pour diriger la stratégie et l'exécution réglementaires dans le domaine des biologiques. Ce poste entièrement à distance offre une influence stratégique sur plusieurs programmes clients et nécessite une expérience solide en affaires réglementaires CMC.

Benefits

Environnement de travail flexible

Possibilité d'évolution professionnelle

Travail avec des clients de premier plan

Qualifications

• 8-12 ans d'expérience en affaires réglementaires CMC.
• Solide expertise des biologiques (mAbs, thérapies géniques).
• Expérience antérieure en environnement de consultation, CRO, ou biotechnologie agile.

Responsibilities

• Développer et mettre en œuvre des stratégies réglementaires CMC.
• Préparer et soumettre des INDs, IMPDs, BLAs.
• Mentorer les membres juniors de l'équipe réglementaire.

Skills

Management des parties prenantes

Communication

Expertise en biologiques

Job description

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Associate Director, Regulatory Affairs CMC, chelmsford

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Client:

AL Solutions

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

1

Posted:

31.05.2025

Expiry Date:

15.07.2025

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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