Our client is currently looking for a qualified Regulatory Strategist to join their dynamic Global Regulatory Team. This team plays a crucial role in shaping regulatory product strategies and overseeing regulatory efforts throughout the development stage and post-marketing of drug products.
Job Description
As a Regulatory Strategist, you will be a key member of the Global Regulatory Team and a strategic partner to the Global Regulatory Lead. Your role involves leveraging regulatory expertise to contribute to the definition of global regulatory strategies, driving the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including interactions with Health Authorities.
Responsibilities
- Provide regulatory expertise to ensure business objectives are met.
- Contribute to the development of a harmonized regulatory voice in committees and forums.
- Represent GRT positions at regulatory forums/committees, as requested.
- Serve as a regional regulatory lead and point of contact with Health Authorities.
- Identify and mitigate regulatory risks using standardized methodologies.
- Lead Health Authority meetings, submission teams, and develop engagement plans for assigned products.
Profile
- Master or PhD (or equivalent) in a relevant scientific discipline.
- Minimum of 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience.
- Proven business acumen, leadership, influencing, and negotiation skills.
- Effective communication skills, both oral and written, with a preference for strong presentation skills.
- Familiarity with electronic document management systems, e.g., Veeva Vault, is preferred.
- Demonstrated ability to handle multiple projects/deliverables simultaneously.
- Strong sensitivity for a multicultural/multinational environment.
Practical information and Benefits
- Region: Amsterdam
- Salary indication: 8000-12000 / freelance possible.
- Contract type: contractor or Freelance.
- Full-time position for maternity leave.
- Vacancy number: 24019
