Associate Director, Regulatory Affairs CMC

JR United Kingdom; Hemel Hempstead; Remote; GBP 70,000 - 100,000; Full time

Job summary

Une entreprise de conseil en sciences de la vie en pleine croissance recherche un Associate Director en affaires réglementaires CMC pour diriger la stratégie et l'exécution réglementaire à travers un portfolio dynamique. Ce rôle pleinement remote est destiné aux professionnels expérimentés, impliquant un impact stratégique significatif, une interaction avec divers clients biopharmaceutiques, et une possibilité de progression de carrière dans un environnement collaboratif.

Benefits

Environnement de travail flexible et entièrement remote

Exposition à des biologiques de pointe

Opportunité de progression de carrière

Qualifications

• 8–12 ans d'expérience en affaires réglementaires CMC.
• Expérience prouvée dans la soumission globale de produits.
• Compréhension scientifique solide du développement de médicaments.

Responsibilities

• Diriger le développement et la mise en œuvre des stratégies réglementaires CMC.
• Servir de point de contact principal pour les projets clients.
• Préparer, examiner et soumettre des documents réglementaires.

Skills

Communication

Gestion des parties prenantes

Expertise en biologiques

Job description

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Associate Director, Regulatory Affairs CMC, hemel hempstead

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Client:

AL Solutions

Location:

hemel hempstead, United Kingdom

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