Job Description
Join BioPharma Innovations AG, a leader in next-generation therapeutics, as our new Senior Regulatory Affairs Specialist. We are dedicated to accelerating the delivery of life-changing medicines to patients across Europe and beyond. In this pivotal role, you will serve as the guardian of our regulatory integrity, ensuring all submissions to the Swissmedic and EMA are flawless, timely, and aligned with the highest industry standards.
We are looking for a strategic thinker with a passion for regulatory science to navigate the complex landscape of drug development. You will lead cross-functional teams, manage the full lifecycle of regulatory dossiers, and drive the strategic positioning of our product pipeline.
Why Join Us?
- Impactful Work: Play a direct role in bringing innovative treatments to market.
- Competitive Compensation: Attractive salary package including performance bonuses.
- Modern Environment: Work in a state-of-the-art facility in the heart of Zurich.
Responsibilities
- Submission Management: Lead the preparation, submission, and maintenance of regulatory dossiers (CTA, MAA, NDA) for Swissmedic and EMA submissions, ensuring 100% compliance with local and international regulations.
- Regulatory Strategy: Develop and implement regulatory strategies to optimize market access and lifecycle management for our clinical programs.
- Legislative Monitoring: Proactively monitor and analyze changes in EU and Swiss regulatory guidelines, translating them into actionable internal policies.
- Stakeholder Liaison: Act as the primary point of contact for Swissmedic and EMA authorities, managing correspondence and preparing for audits or inspections.
- Project Leadership: Oversee cross-functional regulatory projects, coordinating with Clinical Operations, Medical Affairs, and Quality Assurance teams to ensure alignment.
- Documentation: Ensure the accuracy and integrity of all regulatory documentation, including amendments, variations, and periodic safety update reports (PSURs).
Qualifications
- Education: Master’s degree in Pharmacy, Life Sciences, Pharmacology, or a related field.
- Experience: Minimum of 5-7 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with specific experience in Swissmedic and EMA submissions.
- Technical Knowledge: In-depth knowledge of GMP, GCP, and ICH guidelines. Familiarity with regulatory information systems (e.g., RegOnline, RIMS) is highly preferred.
- Language: Fluent in English and German (written and verbal); working knowledge of French is a plus.
- Skills: Exceptional attention to detail, strong analytical skills, and the ability to manage multiple priorities under tight deadlines.
- Soft Skills: Excellent communication skills with the ability to influence stakeholders and present complex regulatory concepts clearly.