Senior Manager, CMC Regulatory Affairs

Senior Manager, CMC Regulatory Affairs

Location: Hertfordshire (Hybrid, 2 days onsite)

Position: Permanent, Full-Time

Cpl Life Sciences is partnering with a leading global pharmaceutical company with a broad portfolio spanning innovative medicines across multiple therapeutic areas. The organisation is committed to advancing treatments that improve patient outcomes worldwide and offers a highly collaborative, science-driven environment where Regulatory Affairs plays a strategic role throughout the product lifecycle.

This is an excellent opportunity for an experienced CMC Regulatory Affairs professional to lead global CMC regulatory activities across both development-stage and commercial products, working closely with cross-functional teams including Pharmaceutical Development, Manufacturing, Quality, Analytical Development and Global Regulatory Affairs.

As Senior Manager, CMC Regulatory Affairs, you will be responsible for developing and executing global CMC regulatory strategies that support product development, registration, lifecycle management and post-approval regulatory compliance.

You will act as the CMC Regulatory lead for multiple projects, providing strategic guidance on complex technical, quality and regulatory issues while ensuring alignment with global health authority expectations.

This position offers significant exposure to late-stage development programmes, global registrations, product lifecycle management activities and agency interactions across key international markets.

Key Responsibilities

Global CMC Regulatory Strategy

• Develop and implement global CMC regulatory strategies for development and marketed products.
• Provide strategic regulatory input to cross-functional project teams from early development through registration and post-approval maintenance.
• Assess regulatory risks and develop mitigation plans to support successful submissions and approvals.
• Act as the primary CMC Regulatory representative within cross-functional development teams.

Regulatory Submissions & Authoring

• Lead the preparation, review and delivery of high-quality CMC regulatory documentation for:
  • INDs, IMPDs and CTAs
  • NDAs, BLAs and MAAs
  • Variations, supplements and renewals
  • Global lifecycle management activities
  • Author and review CTD Module 3 documentation covering:
  • Drug Substance
  • Drug Product
  • Manufacturing processes
  • Process validation
  • Analytical methods and validation
  • Control strategies
  • Stability programmes
  • Comparability assessments
  • Coordinate submission activities across global markets and regional regulatory teams.

Technical CMC Leadership

• Provide regulatory guidance on pharmaceutical development, manufacturing, analytical development and quality-related activities.
• Support process changes, manufacturing transfers, scale-up activities and technology transfer programmes.
• Review and assess proposed changes from Quality, Manufacturing and Technical Operations teams and determine the associated regulatory impact.
• Partner with SMEs to ensure technical data packages meet current regulatory expectations and ICH requirements.

Health Authority Interactions

• Support regulatory agency interactions including scientific advice meetings, briefing documents and responses to agency questions.
• Lead preparation of responses to CMC-related deficiencies, information requests and regulatory commitments.
• Maintain awareness of emerging global CMC regulatory expectations and industry best practices.

Continuous Improvement

• Drive improvements to internal regulatory processes, compliance standards and operational efficiencies.
• Contribute to regulatory intelligence activities and interpretation of evolving CMC guidance.

Candidate Profile

Essential Experience

• Degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Pharmacy or related Life Science discipline.
• Significant experience within CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Proven experience supporting global product development and registration activities.
• Strong understanding of ICH, FDA, EMA and international CMC regulatory requirements.
• Experience authoring and reviewing CTD Module 3 documentation.
• Ability to interpret complex technical, manufacturing and quality data and translate it into effective regulatory strategies.

Technical Expertise

Candidates should possess a strong understanding of:

• Drug substance and drug product development
• Pharmaceutical manufacturing processes
• Analytical development and validation
• Process validation and continued process verification
• Stability strategies and shelf-life justification
• Change control and lifecycle management
• Quality risk management principles
• GMP and quality systems
• CMC requirements across global regulatory markets

Preferred Experience

• Advanced degree (MSc, PhD or PharmD) in a scientific discipline.
• Experience supporting both small molecule and biologic products.
• Experience leading CMC aspects of major regulatory submissions and approvals.
• Direct experience interacting with regulatory agencies on CMC matters.

What's on Offer

• Competitive base salary
• Annual bonus
• Car allowance
• Hybrid working model (2 days onsite)
• Comprehensive benefits package
• Ongoing professional development and career progression opportunities
• Collaborative international environment with significant visibility across global regulatory and development teams

Apply

If you are an experienced CMC Regulatory professional seeking a strategic global role with exposure to complex development and lifecycle management activities, we'd be delighted to discuss this opportunity further.

Please reach out to [email protected]