Job Description
Are you a strategic leader in the pharmaceutical landscape? BioGenesis Innovations is seeking a highly skilled Senior Regulatory Affairs Specialist to join our elite Regulatory Affairs team in Boston, MA. In this pivotal role, you will oversee the submission and approval processes for novel therapeutics, ensuring full compliance with global health authority standards.
At BioGenesis, we don't just follow regulations; we set the standard for excellence in drug development. You will work in a fast-paced, innovative environment where your expertise directly impacts patient lives. We offer a competitive benefits package, continuous learning opportunities, and a culture that champions scientific curiosity and integrity.
Responsibilities
- Lead the preparation and submission of Investigational New Drug (IND) applications and New Drug Applications (NDA) to the FDA and EMA.
- Conduct comprehensive regulatory research to ensure compliance with 21 CFR Part 11, ICH guidelines, and local statutes.
- Manage the Chemistry, Manufacturing, and Controls (CMC) documentation package for product lifecycle management.
- Act as the primary liaison between internal R&D teams and external regulatory bodies during audits and inspections.
- Develop and maintain regulatory strategies to support clinical trial progression and product registration.
- Monitor global regulatory changes and implement necessary updates to company policies and procedures.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related scientific field.
- Minimum of 5+ years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Deep understanding of FDA and EMA regulatory frameworks, including Pre-IND meetings and PMAs.
- Strong proficiency in regulatory information management systems (e.g., TrackWise, Veeva Vault).
- Exceptional written and verbal communication skills, with the ability to articulate complex scientific data to diverse stakeholders.
- Proven track record of successfully navigating complex regulatory pathways and managing tight submission deadlines.