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Product Life Group Logo Product Life Group · Research and Development

Ra Strategy Expert

Netherlands · Job Posted April 16, 2026
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Job Description

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 RA Strategy 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.

Job Responsibility

  • 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

Requirements

  • PhD or MSc in Pharmacy, Medical Biology, Chemistry, or Life Sciences
  • Minimum 10 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
  • 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
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