ProductLife Group (PLG) is a global provider of outsourcing and consulting services for the life sciences industry. We support our clients in achieving regulatory compliance and accelerating their product development and market access. With a strong presence across Europe, North America, and Asia, PLG is committed to delivering excellence through innovation, collaboration, and expertise.

We are seeking a seasoned Regulatory Affairs Strategy Expert (RAS Expert) to lead and execute regulatory strategies for multiple client projects. This is a strategic and client-facing role, ideal for someone with deep regulatory knowledge and strong leadership capabilities.

Group 10
Responsibilities:

  • Lead the overall regulatory strategy and execution for assigned projects.
  • Define global regulatory strategies, including RSPs, Target Product Profiles, roadmaps, and scientific advice.
  • Conduct gap analyses and due diligence, translating findings into actionable strategies across CMC, non-clinical, and clinical domains.
  • Manage regulatory procedures, including:
    • CTIS/IND
    • Orphan Drug Designations (EU & US)
    • Pediatric Investigational Plans (EU & US)
    • Scientific Advice (EU & US)
    • Early Access Programs
    • MAA/NDA/BLA/ANDA
    • Variations, renewals, and supplements
  • Oversee the preparation of regulatory dossiers and submissions.
  • Lead project teams and health authority interactions.
  • Mentor and train staff on RAS activities.

Group 12
Experience:

Education:

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

Experience:

  • Minimum 7 years in regulatory affairs or related strategic roles.
  • Proven experience working with EMA, NCAs, and preferably the US FDA.
  • Experience across multiple disciplines and international regulatory environments.
  • Experience working with large molecules.
  • Strong background in pre-marketing activities.
  • Demonstrated ability to independently manage the role, including full project ownership and interactions with clients and health authorities.
  • Scientific writing experience is a plus.

Skills:

  • In-depth knowledge of pharmaceutical legislation and best practices.
  • Excellent communication and presentation skills in English.
  • Strong writing, analytical, and problem-solving abilities.
  • Strategic thinking and decision-making capabilities.
  • Project management and multitasking proficiency.
  • Diplomatic and flexible approach to stakeholder management.
  • Ability to perform under pressure with limited resources.
  • Proficiency in MS Office tools.

Regulatory Affairs Strategy Expert (RAS Expert)

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