Job Description
Are you passionate about shaping the future of healthcare? BioPharma Innovations is looking for a highly skilled Senior Regulatory Affairs Specialist to join our elite team in Boston. In this pivotal role, you will oversee the regulatory strategy for our groundbreaking drug development pipelines, ensuring compliance with global standards while driving market access and accelerating time-to-market for life-saving therapies.
At BioPharma Innovations, we don't just follow regulations; we set the standard for excellence. You will work alongside world-class scientists and strategists in a dynamic environment that rewards innovation, integrity, and impact. If you are ready to take your career to the next level in the heart of the biotech hub, we want to hear from you.
Why Join Us?
At BioPharma Innovations, we don't just follow regulations; we set the standard for excellence. You will work alongside world-class scientists and strategists in a dynamic environment that rewards innovation, integrity, and impact. If you are ready to take your career to the next level in the heart of the biotech hub, we want to hear from you.
Why Join Us?
- Competitive base salary and comprehensive benefits package.
- Opportunity to work on cutting-edge biologics and small molecule drugs.
- Professional development and leadership training programs.
Responsibilities
- Lead the preparation, submission, and maintenance of complex regulatory filings (NDA, BLA, ANDA) to the FDA and international health authorities.
- Act as the primary liaison between the company and regulatory agencies, managing all correspondence and inquiries.
- Conduct comprehensive regulatory gap analyses and develop strategic remediation plans to ensure full compliance.
- Manage the internal audit preparation and facilitate successful regulatory inspections (Pre-Approval Inspections).
- Monitor evolving global regulatory landscapes and implement necessary compliance updates across the organization.
- Collaborate with R&D, Clinical Operations, and Quality Assurance teams to ensure seamless integration of regulatory requirements.
Qualifications
- Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Advanced degree (MS, PhD, or PharmD) in Life Sciences, Pharmacy, or related field is strongly preferred.
- Professional certification (RAC) is a significant plus.
- Deep understanding of FDA regulations, including 21 CFR Part 11 and 21 CFR Part 312.
- Exceptional analytical skills with a meticulous attention to detail in document preparation.
- Strong project management skills with the ability to manage multiple timelines and priorities.