Shaping EU regulatory strategy to accelerate safe, compliant, and successful product development.
Proclinical is seeking an EU Regulatory Affairs Specialist to join a dynamic team. In this role, you will contribute to the development and implementation of EU clinical regulatory strategies for products in development or post-MAA approval. This position involves close collaboration with the EU Regulatory Lead to identify potential regulatory risks and develop effective mitigation strategies. The role requires maintaining high ethical standards and ensuring compliance with regulatory requirements, company policies, and industry standards. Occasional travel to the Maidenhead office may be required.
Responsibilities:
1. Develop and implement EU regional clinical regulatory strategies aligned with business objectives.
2. Collaborate with the EU Regulatory Lead to proactively identify regulatory risks and devise mitigation strategies.
3. Ensure compliance with relevant regulatory requirements, company policies, and industry standards.
4. Contribute to the development and oversight of regulatory filings, including content and timelines.
5. Act as a key member of the regulatory project team, supporting global clinical development and product lifecycle management.
Key Skills and Requirements:
6. Strong understanding of EU regulatory requirements and processes.
7. Experience in developing and implementing regulatory strategies for clinical development or post-MAA approval products.
8. Ability to identify regulatory risks and develop effective mitigation strategies.
9. Excellent communication and collaboration skills to work effectively within a team.
10. High ethical standards and commitment to compliance with industry regulations.