Job Description
Are you ready to shape the future of medicine? BioGenix Therapeutics is expanding our regulatory affairs division in the heart of Boston’s biotech corridor. We are looking for a detail-oriented Senior Regulatory Affairs Specialist to lead the regulatory strategy for our next-generation biologics.
In this pivotal role, you will ensure our innovations meet the highest standards of safety and efficacy while navigating complex global regulations. Join us in making a tangible impact on patient lives worldwide and advance your career with a leader in the biopharmaceutical industry.
Responsibilities
- Lead Regulatory Submissions: Spearhead the preparation, compilation, and submission of regulatory documents (eCTD, NDA, BLA) to the FDA and international health authorities.
- Regulatory Monitoring: Proactively monitor and interpret changes in global regulatory frameworks to ensure our product pipeline remains compliant with evolving laws.
- Correspondence Management: Manage the regulatory correspondence lifecycle, drafting clear and precise responses to agency queries and submissions.
- Cross-Functional Collaboration: Collaborate closely with R&D, Quality Assurance, and Clinical Operations to resolve complex compliance issues and support product lifecycle management.
- Documentation Control: Oversee the maintenance, archiving, and version control of regulatory master files and submission packages.
Qualifications
- Education: Bachelor’s degree in Biology, Chemistry, Pharmacology, or related scientific field; Master’s degree is preferred.
- Experience: Minimum of 5-7 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Certification: RAC (Registered Regulatory Affairs Professional) certification is highly preferred.
- Technical Knowledge: In-depth knowledge of 21 CFR Part 11, GMP, and FDA submission processes (e.g., CMC, Pre-IND/IND).
- Communication: Exceptional written and verbal communication skills with the ability to translate complex technical data into clear regulatory documents.