Director, CMC & Regulatory Sciences

Overview

As Director of CMC & Regulatory Sciences in the Biologics unit, you lead regulatory strategy and CMC execution across development to commercialization. You will guide a specialist team, align CMC activities with global regulatory expectations, and act as a senior advisor to clients and projects. Your leadership helps shape strategy and drive delivery excellence for biologics programmes. This role offers impact across regulatory submissions, technology transfer, and quality processes within a global CRO.

Pay / Benefits

• Competitive salary

Responsibilities

• Lead the CMC and regulatory function for biologics with strong scientific and regulatory expertise and up-to-date knowledge of global regulatory requirements
• Develop and implement CMC regulatory strategies across a diverse portfolio of biologics development programmes
• Monitor and interpret changes to global regulatory requirements (FDA, EMA, MHRA, NMPA, ICH) and advise on actions
• Sustain a high-performing team through coaching, objective setting, and succession planning
• Define and deliver talent and capability strategy for the CMC & Regulatory Sciences function
• Ensure project and contract delivery while enhancing Pharmaron's scientific and regulatory reputation
• Provide expert CMC consultancy to clients across development programmes and advisory on submissions
• Lead or support preparation and review of regulatory submissions (IND, IMPD, BLA, MAA)
• Collaborate with Process, Analytical, Quality and operations teams to integrate CMC needs into delivery
• Act as senior technical escalation point for complex problems in science, regulation, and operations
• Oversee validation strategies for manufacturing, analytical methods, and cleaning procedures
• Ensure validation activities meet regulatory and client requirements and are inspection-ready
• Act as CMC Sponsor for key client programmes to align client expectations with delivery teams
• Identify and manage business, regulatory and operational risks to enable timely decisions
• Lead process improvement and capability development across the organisation
• Deliver CMC training to internal stakeholders to broaden regulatory knowledge
• Represent Pharmaron in client meetings, technical discussions, and industry forums

Key requirements

• PhD or MSc in Life Sciences, Chemistry, Biochemistry or related field
• Significant experience in CMC, Regulatory Affairs or Biologics Development within CRO/CDMO/biopharma
• Proven track record in developing CMC regulatory strategies and supporting submissions
• Strong knowledge of FDA, EMA, MHRA and ICH guidelines
• Experience with process validation, analytical method validation and GMP manufacturing
• Commercially oriented with ability to translate delivery and client relationships into growth
• Experience managing specialist scientific or regulatory teams and developing staff
• Strong leadership with a lead-by-example approach
• Excellent written and oral communication for complex CMC/regulatory info
• Strong interpersonal, stakeholder management, and influencing skills
• Ability to adapt quickly to changing priorities and global matrix environments

• leadership by example
• client relationship focus
• strategic thinking
• CMC regulatory strategy
• regulatory submissions (IND/IMPD/BLA/MAA)
• process validation

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