ProductLife Group (PLG) is a global leader in outsourcing and consulting services for the life sciences industry. We help clients navigate complex regulatory landscapes, accelerate product development, and ensure compliance across global markets. Our collaborative and innovative culture empowers professionals to make a meaningful impact in healthcare.

We are looking for an experienced Regulatory Affairs CMC Expert (RA CMC Expert) to lead and execute Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for multiple client projects. This role is ideal for someone with deep technical expertise, strategic insight, and strong communication skills.

Group 10
Responsibilities:

  • Lead the overall RA CMC strategy and execution for assigned projects.
  • Define global RA CMC strategies, including health authority interaction opportunities.
  • Chair and lead project teams and maintain client communication.
  • Conduct gap analyses and due diligence for customer projects.
  • Translate gaps into actionable CMC data generation strategies.
  • Provide technical writing for:
    • IND eCTD Modules 2.3 and 3
    • QIMPD-EU
    • BLA/MAA submissions
    • Variations and supplements
  • Write and review CMC-related documentation, including:
    • ODD, PIP, Briefing Books, labeling
    • PRIME and RMAT applications
  • Review non-Module 3 CMC-related content (e.g., Nitrosamine Risk Assessments, ERA, Non-Clinical and Clinical Overviews).
  • Support clients with submissions and health authority queries.

Group 12
Experience:

Education:

  • PhD or MSc in Pharmacy, Chemistry, or Life Sciences.

Experience:

  • Minimum 7 years in regulatory affairs with a focus on CMC.
  • Proven experience working with large molecules.
  • Experience with EMA, FDA, and other health authorities.
  • Familiarity with full CTD (Modules 1–5) and GMP principles.
  • Proven track record in pharmaceutical lifecycle management and RA CMC requirements globally.
  • Demonstrated ability to manage pre-marketing activities and full project ownership independently.
  • Experience in client and health authority interactions across global regions.
  • Scientific writing experience is a plus.

Skills:

  • Excellent communication and presentation skills in English.
  • Strong technical writing and editing capabilities.
  • Analytical, problem-solving, and data management skills.
  • Strategic thinking and leadership abilities.
  • Effective project and time management.
  • Flexible, diplomatic, and resilient under pressure.
  • Proficiency in MS Office tools.

Regulatory Affairs CMC Expert - VAF 403

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