Regulatory Strategy Expert
ProductLife Group · EMEA
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- Hybrid
- Full-time
- $150,000 / year
- EMEA
Job highlights
- Lead global regulatory strategies for life sciences projects.
- Define RSPs, TPPs, roadmaps, and scientific advice.
- Manage complex regulatory procedures and health authority interactions.
- Oversee regulatory dossier preparation and submission processes.
- Mentor teams and ensure compliance for clients.
About the role
About ProductLife Group
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.
Key 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
Requirements
Education
- PhD or MSc in Pharmacy, Medical Biology, Chemistry, or Life Science
Experience
- 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
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
Key skills/competency
- Regulatory Strategy
- EMA
- FDA
- CMC
- Clinical Trials
- Dossier Preparation
- Pharmaceutical Legislation
- Project Management
- Scientific Writing
- Life Sciences
Skills & topics
- Regulatory Strategy Expert
- Regulatory Affairs
- Life Sciences Consulting
- Pharmaceutical Strategy
- EMA
- FDA
- Regulatory Compliance
- Product Development
- Global Regulatory Affairs
- RA Strategy
How to get hired
- Tailor your resume: Highlight 10+ years of regulatory affairs experience, EMA/FDA interactions, and pre-marketing expertise.
- Showcase strategic thinking: Emphasize your ability to define global regulatory strategies and translate analyses into actionable plans.
- Demonstrate leadership: Provide examples of managing projects, leading teams, and interacting with health authorities independently.
- Prepare for interviews: Be ready to discuss your experience with specific regulatory procedures and large molecule development.
- Understand PLG: Research ProductLife Group's global presence and commitment to client success in the life sciences.
Technical preparation
Master EMA and FDA submission requirements.,Study guidelines for orphan drugs and PIPs.,Practice CMC, non-clinical, and clinical strategy planning.,Review scientific writing for regulatory dossiers.
Behavioral questions
Describe a complex regulatory strategy you led.,How do you manage health authority interactions under pressure?,Tell me about mentoring junior regulatory staff.,How do you translate gap analyses into actionable plans?
Frequently asked questions
- What is the primary focus of the Regulatory Strategy Expert role at ProductLife Group?
- The Regulatory Strategy Expert at ProductLife Group is responsible for leading and executing regulatory strategies for life sciences clients. This includes defining global strategies, conducting analyses, managing various regulatory procedures, and interacting with health authorities.
- What educational background is preferred for the Regulatory Strategy Expert position?
- ProductLife Group prefers candidates with a PhD or MSc in Pharmacy, Medical Biology, Chemistry, or other Life Science fields for the Regulatory Strategy Expert role.
- How much experience is required to be considered for the Regulatory Strategy Expert role?
- A minimum of 10 years of experience in regulatory affairs or related strategic roles is required. Proven experience with regulatory bodies like the EMA and FDA is also essential.
- Does the Regulatory Strategy Expert role involve international regulatory experience?
- Yes, the role requires experience across multiple disciplines and international regulatory environments, including significant experience with the EMA and preferably the US FDA.
- What types of regulatory procedures will the Regulatory Strategy Expert manage?
- The Regulatory Strategy Expert will manage a wide range of procedures including CTIS/IND, Orphan Drug Designations, Pediatric Investigational Plans, Scientific Advice, Early Access Programs, MAA/NDA/BLA/ANDA, and variations/renewals.
- What are the key skills needed for this role at ProductLife Group?
- Key skills include in-depth knowledge of pharmaceutical legislation, excellent communication, strong analytical and problem-solving abilities, strategic thinking, project management, and the ability to perform under pressure.
- Is scientific writing experience a requirement for the Regulatory Strategy Expert position?
- Yes, scientific writing experience is listed as a requirement, alongside the ability to oversee the preparation of regulatory dossiers and submissions.
- What is the work arrangement for the Regulatory Strategy Expert at ProductLife Group?
- While not explicitly stated, the description implies a client-facing and project leadership role, suggesting a hybrid or on-site arrangement may be most common, though remote possibilities might exist depending on project needs and location.