Job Description
Are you a dedicated professional passionate about advancing life sciences? Apex BioPharma Solutions is seeking a highly skilled Senior Regulatory Affairs Specialist to join our dynamic team in Boston, Massachusetts. We are at the forefront of biotechnology innovation, dedicated to developing breakthrough therapies that change lives. In this pivotal role, you will lead our regulatory strategy, ensuring our products meet the highest standards of safety, efficacy, and compliance.
We offer a collaborative environment, competitive benefits, and the opportunity to work on cutting-edge projects that have a real-world impact.
Responsibilities
- Lead the preparation, submission, and maintenance of regulatory documents for INDs, NDAs, and BLAs with the FDA and EMA.
- Oversee the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions.
- Act as the primary liaison between internal cross-functional teams (R&D, Quality, Clinical) and external regulatory authorities.
- Develop and implement regulatory strategies to expedite product development timelines.
- Manage change control and ensure compliance with 21 CFR Part 11 and GLP/GMP standards.
- Conduct periodic regulatory audits and prepare for inspections.
Qualifications
- Master’s degree in Chemistry, Biology, Pharmacy, or related scientific field; PharmD or PhD preferred.
- Minimum of 5+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Deep understanding of FDA and EMA regulatory guidelines and submission processes.
- Proven track record of successfully managing IND or NDA submissions.
- Excellent written and verbal communication skills with the ability to interpret complex regulatory data.
- Strong project management skills with the ability to prioritize multiple deadlines.