About Us: We are a dynamic and growing medical communications agency committed to excellence in pharmaceutical communications. As we expand our regulatory department, we are actively seeking a talented and experienced European Principal Regulatory Writer to join our team.
Role Overview: As a Principal Regulatory Writer, you will play a pivotal role in translating complex scientific and clinical data into compelling regulatory documents. Your expertise will be crucial in ensuring compliance with European regulations and industry standards.
Fully remote role
Key Responsibilities:
1. Regulatory Expertise: Leverage your in-depth knowledge of European regulations to contribute to the development of high-quality regulatory documents, including but not limited to clinical study reports, regulatory submissions, protocols, investigator brochures, and marketing authorization applications.
2. Technical Mastery: Dive into the technical details of scientific and clinical data, demonstrating a keen ability to synthesize and present information accurately and coherently. Stay abreast of industry advancements and regulatory updates to ensure the highest standards of technical accuracy.
3. Collaborative Engagement: Work collaboratively with cross-functional sponsor teams, bridging the gap between regulatory affairs, clinical teams, and other stakeholders. Your effective communication skills wi...