Job Description
Join the Future of Healthcare
Roche is seeking a highly motivated Senior Regulatory Affairs Specialist to join our dynamic team in Basel. In this pivotal role, you will drive the regulatory strategy for our innovative therapeutics, ensuring compliance with global health authority requirements while accelerating time-to-market for critical medicines.
You will collaborate with cross-functional teams spanning R&D, Pharmacovigilance, and Marketing, acting as the guardian of our product registrations across the EMEA region.
Responsibilities
- Lead the preparation and submission of regulatory dossiers (e.g., MAA, NDA, BLA) to EMA and Health Authorities.
- Develop and execute comprehensive regulatory strategies for new product launches and lifecycle management.
- Liaise directly with Health Authorities and Ethics Committees to address queries and ensure timely approvals.
- Monitor and interpret evolving global regulatory frameworks (EMA, FDA, ICH guidelines) and implement necessary changes.
- Mentor junior regulatory affairs staff and conduct training on regulatory compliance standards.
- Manage the regulatory filing budget and timelines for assigned product portfolios.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, or a related field (PhD preferred).
- Minimum of 5-7 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Deep understanding of EMA procedures and Swissmedic regulations.
- Strong project management skills with the ability to prioritize multiple submissions simultaneously.
- Fluency in English and German (French is a plus).
- Excellent written and verbal communication skills with a keen attention to detail.