Regulatory Strategy Specialist

ProductLife Group; Amsterdam; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A global provider of outsourcing and consulting services is seeking a Regulatory Affairs Strategy Specialist to lead regulatory strategies for client projects. The ideal candidate will have over 5 years of experience in regulatory affairs, a relevant PhD or MSc, and strong knowledge of pharmaceutical legislation. Responsibilities include managing regulatory procedures, conducting gap analyses, and mentoring staff. This role emphasizes leadership in a fast-paced environment, requiring excellent communication and strategic thinking skills.

Qualifications

• Minimum 5 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.
• Scientific writing experience is a plus.

Responsabilités

• Lead the overall regulatory strategy and execution for assigned projects.
• Define global regulatory strategies, including RSPs, Target Product Profiles, and roadmaps.
• Conduct gap analyses and due diligence for regulatory compliance.
• Manage regulatory procedures and oversee the preparation of submissions.
• Lead project teams and health authority interactions.
• Mentor and train staff on RAS activities.

Connaissances

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

Formation

PhD or MSc in Pharmacy, Medical Biology, Chemistry, or Life Science

Description du poste

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 Specialist 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 5 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 capabilitiesProject management and multitasking proficiency
• Diplomatic and flexible approach to stakeholder management
• Ability to perform under pressure with limited resources