Job Description
Are you a visionary professional ready to shape the future of medicine?
BioGenesis Therapeutics is seeking a highly skilled Senior Regulatory Affairs Specialist to join our dynamic team in Boston. In this pivotal role, you will drive the regulatory strategy for our groundbreaking pharmaceutical products, ensuring compliance with global standards while accelerating time-to-market for life-saving therapies.
We offer a competitive benefits package, a state-of-the-art work environment, and the opportunity to collaborate with industry leaders in a mission-driven organization.
Responsibilities
- Lead the end-to-end preparation and submission of regulatory documents (NDA, BLA, ANDA) to the FDA and international authorities.
- Develop and implement comprehensive regulatory strategies to support product lifecycle management.
- Conduct thorough regulatory gap analyses and ensure compliance with ICH, FDA, and EMA guidelines.
- Manage interactions with health authorities, including responses to questions and inquiries.
- Collaborate cross-functionally with R&D, Clinical Operations, and Quality Assurance to streamline regulatory workflows.
- Maintain up-to-date knowledge of global regulatory trends and legislative changes impacting the pharmaceutical industry.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Biology, Chemistry, or a related Life Sciences field.
- Minimum of 5-7 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology sector.
- Deep understanding of FDA regulations, ICH guidelines, and EMA procedures.
- Strong project management skills with the ability to manage multiple concurrent submissions.
- Excellent written and verbal communication skills, with a keen attention to detail.
- Proven track record of successful product registrations in the US market.