Job Description
Are you a strategic thinker ready to shape the future of global healthcare? ApexBio Innovations is looking for a highly experienced Senior Regulatory Affairs Specialist to join our elite team in Basel. In this pivotal role, you will drive the regulatory strategy for our next-generation therapeutics, ensuring compliance with international standards while accelerating time-to-market for life-saving medications.
At ApexBio, we pride ourselves on a culture of excellence, innovation, and collaboration. You will work alongside world-class scientists and regulatory experts in a dynamic environment that rewards initiative and technical mastery.
Responsibilities
- Lead the end-to-end preparation and submission of regulatory dossiers (CTA, MAA, NDA) to the EMA and FDA.
- Manage the regulatory lifecycle for clinical trials, ensuring full compliance with Good Clinical Practice (GCP) and ICH guidelines.
- Liaise with regulatory authorities and cross-functional teams (R&D, Clinical, Medical Affairs) to resolve complex compliance issues.
- Oversee the maintenance of the Regulatory Information Management System (RIMS) and ensure data integrity.
- Conduct gap analyses for product portfolios and develop strategic plans for lifecycle management.
- Present regulatory updates and strategic recommendations to senior leadership.
Qualifications
- Master’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field.
- Minimum of 5-7 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Deep knowledge of EMA, FDA, and PMDA regulations.
- Strong project management skills with the ability to handle multiple priorities in a fast-paced environment.
- Excellent written and verbal communication skills in English and German (fluency is a strong asset).
- Proficiency in regulatory software (e.g., Veeva Vault, RIMS).