Job Description
Join the forefront of biomedical innovation at Helix Therapeutics AG, a leading global biopharmaceutical company headquartered in the heart of the "Pharma Valley" in Basel, Switzerland. We are dedicated to developing breakthrough therapies that change lives.
We are currently seeking a highly motivated and detail-oriented Senior Regulatory Affairs Specialist to join our Regulatory Affairs team. In this pivotal role, you will lead the preparation and submission of regulatory documents for our innovative drug candidates, ensuring compliance with stringent global standards.
Why join us?
- Work in a world-class research environment.
- Competitive compensation package and benefits.
- Opportunity for rapid professional growth.
If you have a passion for regulatory science and a track record of success in the pharmaceutical industry, we want to hear from you.
Responsibilities
- Lead the preparation and submission of regulatory dossiers (CTA, MAA, IND, NDA) to EMA, FDA, and other Health Authorities.
- Manage the entire lifecycle of product registration, including amendments, variations, and supplements.
- Conduct regulatory intelligence searches to monitor changes in legislation and guidelines.
- Liaise with cross-functional teams (Clinical, CMC, Medical) to gather necessary data for submissions.
- Oversee pharmacovigilance reporting and signal detection requirements.
- Ensure all submissions are compliant with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Qualifications
- Master’s degree in Pharmacy, Life Sciences, Biology, or a related scientific field.
- Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Deep understanding of EMA and FDA regulations, including ICH guidelines.
- Fluency in English and German (both written and verbal).
- Strong project management skills with the ability to prioritize multiple competing deadlines.
- Proficient in using electronic submission systems (e.g., EudraCT, CDER Gateway).