Associate Director, Regulatory Affairs CMC

JR United Kingdom; Colchester; Remote; GBP 75,000 - 110,000; Full time

Job summary

Une entreprise de bio-sciences en pleine croissance recherche un Directeur Associé en affaires réglementaires – CMC pour diriger des stratégies réglementaires sur un portefeuille dynamique de programmes biologiques. Ce rôle entièrement à distance est idéal pour un professionnel réglementaire expérimenté, prêt à impacter stratégiquement. Vous serez le principal contact pour des clients biotech, prenant la tête des activités réglementaires CMC, et interagissant avec les autorités. Ce poste offre une influence stratégique et un environnement de travail flexible.

Benefits

Environnement de travail flexible

Progression de carrière dans une société de conseil rapide

Exposition à des biologiques de pointe et des cadres réglementaires mondiaux

Opportunité de travailler avec des clients de premier plan sur les marchés de l'UE et des États-Unis

Qualifications

• 8–12 ans d'expérience en affaires réglementaires CMC avec expertise en biologiques.
• Historique de soumissions globales réussies.
• Compréhension scientifique solide du développement et de la fabrication des médicaments.

Responsibilities

• Développer et mettre en œuvre des stratégies réglementaires CMC pour les biologiques.
• Point de contact principal pour les projets clients et les interactions avec les autorités sanitaires.
• Préparer, réviser et soumettre les IND, IMPD, BLAs, MAAs, variations, et suppléments.

Skills

Leadership

Communication

Stakeholder Management

Scientific Understanding

Job description

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Associate Director, Regulatory Affairs CMC, colchester

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Client:

AL Solutions

Location:

colchester, 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