Job Description
Are you a strategic thinker with a passion for advancing global health? NovaPharma Solutions is seeking a highly skilled Senior Regulatory Affairs Specialist to join our dynamic team in Boston, MA. We are dedicated to developing breakthrough therapies that improve patient outcomes worldwide. In this pivotal role, you will lead the regulatory strategy for our pipeline, ensuring our innovations meet the highest standards of safety, efficacy, and compliance.
We offer a competitive benefits package, a collaborative culture, and the opportunity to work on life-changing projects. If you are ready to take your career to the next level in a premier pharmaceutical environment, we want to hear from you.
Responsibilities
- Lead the preparation and submission of regulatory documents to global health authorities, including FDA, EMA, and PMDA.
- Manage the regulatory lifecycle for product submissions, covering INDs, NDA, BLA, and MAAs.
- Coordinate with cross-functional teams (R&D, Quality, Clinical) to gather and validate scientific data for submissions.
- Ensure strict compliance with local and international regulatory standards and cGMP guidelines.
- Prepare responses to agency inquiries and manage pre-approval inspections and audits.
- Conduct regulatory intelligence analysis to identify trends and opportunities for competitive advantage.
Qualifications
- B.S. in Biology, Chemistry, Pharmacy, or a related scientific field; Master’s degree is preferred.
- Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- In-depth knowledge of FDA 21 CFR Part 11, EMA guidelines, and ICH regulations.
- Strong project management skills with the ability to prioritize multiple high-stakes deadlines.
- Excellent written and verbal communication skills, with a keen attention to detail.
- Experience with regulatory information systems (e.g., Veeva Vault) is a plus.