Job Description
Are you a strategic leader in the pharmaceutical industry looking to make a global impact? BioGenesis Pharma Solutions is seeking a highly experienced Senior Regulatory Affairs Manager to oversee our global compliance strategy and submissions in Basel.
As a key member of our regulatory affairs team, you will be responsible for ensuring our innovative therapies meet all regulatory standards set by Swissmedic and the EMA. You will lead a dedicated team, manage complex product lifecycles, and drive the regulatory strategy that brings life-saving treatments to patients worldwide.
Why Join Us?
- Work with cutting-edge medical technologies.
- Competitive salary package and benefits in Switzerland.
- Opportunity to lead a diverse, international team.
- Commitment to professional development and growth.
What You Will Do
Responsibilities
- Lead and manage the end-to-end regulatory lifecycle for assigned product portfolios, including CTA, MAA, and variation submissions.
- Act as the primary point of contact for Health Authorities (Swissmedic, EMA, FDA) and internal stakeholders.
- Oversee the preparation and review of Chemistry, Manufacturing, and Controls (CMC) documentation and Pharmacovigilance dossiers.
- Develop and execute regulatory strategies to support product launches and lifecycle management.
- Ensure strict compliance with GxP standards, GMP guidelines, and local regulatory requirements.
- Mentor and develop regulatory affairs staff, fostering a culture of excellence and continuous improvement.
- Conduct regulatory intelligence and track changes in global legislation to mitigate risk.
Qualifications
- Master’s degree in Pharmacy, Life Sciences, or a related scientific field.
- Minimum of 7 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Deep technical knowledge of Swissmedic and EMA regulatory processes and guidelines.
- Proven track record of leading regulatory submissions and managing cross-functional projects.
- Excellent leadership, communication, and interpersonal skills.
- Fluency in English and German is required.
- Strong analytical skills with the ability to interpret complex regulatory data.