Associate Director, Regulatory Affairs CMC

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

Job summary

Une société de conseil en sciences de la vie en pleine croissance recherche un Associate Director en affaires réglementaires – CMC pour diriger la stratégie réglementaire et l'exécution à travers un portefeuille dynamique de programmes biologiques. Ce rôle à distance est conçu pour un professionnel réglementaire expérimenté prêt à faire une impact stratégique plus large.

Benefits

Environnement de travail flexible

Progression de carrière

Travail avec des clients de premier plan

Qualifications

• 8–12 ans d'expérience en affaires réglementaires CMC avec expertise en biologiques.
• Historique prouvé de soumissions globales à travers le cycle de vie du produit.
• Expérience dans un environnement de conseil, CRO ou biotech agile souhaitée.

Responsibilities

• Diriger la développement et mise en œuvre de stratégies réglementaires CMC pour les biologiques.
• Servir de point de contact réglementaire principal pour les projets clients.
• Préparer et soumettre des INDs, IMPDs, BLAs, MAAs.

Skills

Regulatory Strategy

Client Management

Scientific Understanding

Biologics Expertise

Communication Skills

Job description

Social network you want to login/join with:

Associate Director, Regulatory Affairs CMC, preston, lancashire

col-narrow-left

Client:

AL Solutions

Location:

preston, lancashire, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

1

Posted:

31.05.2025

Expiry Date:

15.07.2025

col-wide

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