Job Description
Join BioVita Therapeutics, a leading innovator in biopharmaceutical research, as our Senior Regulatory Affairs Specialist. You'll play a pivotal role in navigating complex regulatory landscapes to accelerate life-changing therapies to market. This position offers the opportunity to shape global regulatory strategies while working with cutting-edge scientific teams in our state-of-the-art Cambridge facility.
Responsibilities
- Develop and execute global regulatory strategies for clinical trials and product approvals
- Prepare and submit dossiers to FDA, EMA, and other international health authorities
- Ensure compliance with GMP, GLP, and pharmacovigilance regulations
- Collaborate with R&D and clinical teams to align development plans with regulatory requirements
- Represent the company in regulatory agency meetings and industry forums
- Manage regulatory submissions lifecycle from pre-IND to post-approval
- Mentor junior regulatory staff and stay current with evolving regulatory frameworks
Qualifications
- Masters or PhD in Pharmacy, Life Sciences, or related field
- 5+ years of regulatory affairs experience in pharmaceutical/biotech
- Proven track record with FDA/EMA submissions and inspections
- Deep knowledge of ICH guidelines and global regulatory landscapes
- Exceptional written communication and documentation skills
- Experience with regulatory software (e.g., Veeva Vault RIM)
- Strong analytical skills and attention to detail
- Certified Regulatory Affairs Professional (RAC) preferred