Job Description
Are you a strategic thinker passionate about transforming patient lives through innovative therapeutics? BioMed Solutions AG is seeking a highly skilled Senior Regulatory Affairs Specialist to join our elite team in Basel. In this pivotal role, you will drive the regulatory strategy for our global pipeline, ensuring seamless compliance with EMA, FDA, and Swissmedic standards while accelerating time-to-market for groundbreaking medicines.
Responsibilities
- Lead the preparation and submission of complex regulatory dossiers for clinical trials and marketing authorizations.
- Act as the primary point of contact for global regulatory agencies (EMA, FDA, PMDA).
- Monitor regulatory landscape changes and implement strategic updates across the organization.
- Conduct internal audits and risk assessments to ensure 100% compliance with GxP and local laws.
- Collaborate cross-functionally with R&D, Clinical Operations, and Medical Affairs to align product strategies.
- Mentor junior team members and contribute to the continuous improvement of our regulatory processes.
Qualifications
- Master’s degree or PhD in Pharmacy, Life Sciences, or a related scientific field.
- Minimum of 5-7 years of progressive experience in Regulatory Affairs within the pharmaceutical/biotech industry.
- In-depth knowledge of EMA, FDA, and Swissmedic regulations and submission processes.
- Excellent written and verbal communication skills in English; German is a plus.
- Strong project management skills with the ability to manage multiple priorities in a fast-paced environment.