Associate Director, Regulatory Affairs CMC

JR United Kingdom; Liverpool; Remote; GBP 80,000 - 110,000; Full time

Job summary

Une société de conseil en sciences de la vie en pleine croissance cherche un Associate Director pour diriger la stratégie réglementaire dans un environnement flexible et entièrement distant. Le candidat idéal aura une expérience approfondie en affaires réglementaires CMC et une approche axée sur le client pour influencer plusieurs programmes clients à travers des technologies biologiques avancées.

Benefits

Environnement de travail flexible

Opportunités de progression de carrière

Exposition aux biologiques de pointe

Qualifications

• 8–12 ans d'expérience en CMC Regulatory Affairs.
• Expertise en biologiques, y compris mAbs et thérapies géniques.
• Antécédents prouvés dans les soumissions mondiales.

Responsibilities

• Développer et mettre en œuvre des stratégies réglementaires CMC.
• Point de contact principal pour les projets clients et interactions avec les Autorités de Santé.
• Préparer et soumettre des documents réglementaires et des variétés.

Skills

Regulatory Affairs

Client management

Biologics expertise

Stakeholder management

Job description

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Associate Director, Regulatory Affairs CMC, liverpool

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Client:

AL Solutions

Location:

liverpool, 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