Regulatory Affairs Lead: Clinical Document Expertise
We are seeking a highly skilled Regulatory Affairs professional to lead our clinical document team. As a subject matter expert, you will provide strategic guidance on regulatory consulting services, including strategy and document writing.
Your expertise in clinical documents such as overviews, briefing packages, orphan drug designations, and paediatric investigation plans will be invaluable in driving the growth of our business.
The ideal candidate will have a strong knowledge of European pharmaceutical regulations and guidelines, with significant experience in clinical document review and generation, development, registration, and lifecycle management of medicinal products in Europe.
You will lead complex projects, manage teams, and engage professionally with clients, maintaining relationships with regulatory agencies and professional associations.
We offer an attractive salary package, support for sustainable careers, and the opportunity to thrive in a joyful community that values individuality and partnership.
Key Responsibilities:
* Provide regulatory consulting services, including strategy and document writing.
* Lead development and growth of the clinical document team.
* Manage complex projects ensuring high quality and timely delivery.
* Serve as a regulatory expert in development, registration, and post-licensing activities of pharmaceutical products.
* Line manage and mentor team members, providing guidance and training.
* Engage professionally with clients and build industry networks.
Requirements:
* University degree in life sciences.
* Strong knowledge of European pharmaceutical regulations and guidelines.
* Significant regulatory affairs experience, particularly in clinical document review and generation.
* Excellent communication and negotiation skills.
* Strong organizational skills and analytical mindset.
* Enjoy working in an international environment.
What We Offer:
* Attractive salary package.
* Support for sustainable careers.
* Opportunity to thrive and grow within a joyful community.