Sr Mgr. Regulatory Affairs

Regeneron Pharmaceuticals, Inc; Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading science-based biopharmaceutical company in Paris seeks a Senior Manager in Regulatory Affairs. You will develop and implement regulatory strategies for innovative programs in metabolism and ophthalmology, ensuring compliance with EU regulations. Candidates must have 4+ years of regulatory experience, a scientific degree, and strong communication skills. Join us in shaping the future of healthcare.

Qualifications

• 4+ years of regulatory experience in clinical development.
• Experience with the European Medicines Agency (EMA) preferred.
• Strong track record in supporting Clinical Trial Applications.

Responsabilités

• Develop and implement regulatory strategies for programs.
• Lead preparation and submission of Clinical Trial Applications.
• Conduct analyses of clinical and preclinical data.
• Review clinical protocols and study reports.
• Lead EU Scientific Advice requests and meetings.

Connaissances

Regulatory strategy development

EU regulatory requirements

Clinical Trial Applications

Cross-team collaboration

Data analysis

Verbal communication

Written communication

Formation

Advanced degree in a scientific field

Description du poste

We are Regeneron, a leading science-based biopharmaceutical company dedicated to transforming lives through ground-breaking medicines. Our mission is to address high unmet medical needs across a range of therapeutic areas, including ophthalmology, oncology, cardiovascular, allergic, inflammatory, infectious, and rare diseases. As a Senior Manager, Regulatory Affairs (EU), you will play a meaningful role in crafting the future of global healthcare by driving regulatory strategies and ensuring compliance for our innovative development programs in metabolism and ophthalmology.

This is your chance to create a meaningful impact on patients’ lives while collaborating with a team of elite scientists and regulatory professionals.

In a typical day you will:

• Develop and implement regulatory strategies for assigned programs in collaboration with global development teams.
• Lead the preparation and submission of Clinical Trial Applications (CTAs) via the Clinical Trials Information System (CTIS) to multiple EU member states.
• Lead regulatory activities such as CTA amendments, annual reports, and other key submissions.
• Conduct critical analyses of clinical and preclinical data, providing interpretations and conclusions to guide decision-making.
• Review clinical protocols and study reports to ensure alignment with EU regulatory requirements.
• Lead the preparation and execution of EU Scientific Advice requests, including meetings with the European Medicines Agency (EMA) and other national agencies.
• Stay ahead of the curve by monitoring and interpreting new EU Commission and EMA guidelines, and provide training to scientific staff as needed.
• Represent Regeneron in interactions with external stakeholders, including EMA scientific committees, EU national agencies, and industry associations.

This role may be for you if you:

• Thrive on developing and implementing regulatory strategies that drive innovation and compliance.
• Have a proven track record navigating the complexities of EU regulatory requirements, including Clinical Trial Applications and interactions with the EMA.
• Are passionate about advancing groundbreaking treatments in metabolism and ophthalmology.
• Excel in establishing relationships and influencing collaborators across diverse teams.
• Are diligent, with a talent for analyzing data and crafting clear, concise regulatory documents.
• Enjoy collaborating with multidisciplinary teams to solve challenges and achieve shared goals.
• Are proactive in staying informed about emerging regulatory trends and guidelines.

To Be Considered:

You must have a minimum of 4+ years of regulatory experience focused on supporting products through clinical development. An advanced degree in a scientific field is required, and experience with the EMA (e.g., scientific advice, orphan designation, Pediatric Investigation Plans) is highly preferred. A consistent record of supporting EU Clinical Trial Applications through approval and study start-up is crucial.

Preferred qualifications include experience in regulatory strategy for metabolism or ophthalmology programs, as well as marketing authorization applications or lifecycle management of approved products via the centralized procedure. Strong written and verbal communication skills, along with the ability to negotiate and clearly articulate positions to partners, are critical for success in this role.

Join us in shaping the future of medicine while advancing your career in a dynamic, collaborative, and inclusive environment. Together, we can make a difference.

Apply today to be part of our mission to transform lives.