Job Description
Lead the Future of Healthcare Compliance in Basel
BioPharma Innovations AG is a global leader in therapeutic development, renowned for our commitment to quality and patient safety. We are seeking a detail-oriented and strategic Senior Regulatory Affairs Specialist to join our dynamic Basel-based team. In this pivotal role, you will oversee the regulatory strategy for our product pipeline, ensuring full compliance with global health authority requirements. If you possess a keen eye for detail and a passion for the pharmaceutical industry, we want to hear from you.
Why Join Us?
- Work with cutting-edge biotechnology in the heart of Europe’s pharmaceutical hub.
- Competitive salary package and comprehensive benefits.
- Commitment to professional development and continuous learning.
- A collaborative, inclusive, and innovative work environment.
Responsibilities
- Manage the end-to-end lifecycle of regulatory submissions for EMA, FDA, and other global health authorities.
- Lead the preparation and review of complex regulatory dossiers, including CMC, non-clinical, and clinical data.
- Coordinate cross-functional activities between R&D, Quality, and Medical Affairs to ensure compliance.
- Monitor changes in global regulatory guidelines and implement necessary updates to internal SOPs.
- Represent the company in regulatory meetings and liaison with health authorities.
- Conduct gap analyses to ensure ongoing compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
Qualifications
- Master’s degree in Pharmacy, Life Sciences, Biology, or a related field.
- Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology sector.
- Strong working knowledge of EudraLex, ICH guidelines, and FDA regulations (21 CFR Part 312/314).
- Fluency in English and German (written and verbal) is essential.
- Excellent project management skills with the ability to manage multiple timelines simultaneously.
- Strong analytical problem-solving skills and attention to detail.