Job Description
Join the forefront of medical innovation with Apex Therapeutics Group. We are a dynamic biotechnology firm dedicated to developing breakthrough therapies for complex diseases. We are currently seeking a highly skilled Senior Regulatory Affairs Specialist to join our Regulatory Affairs team in Cambridge, MA.
In this critical role, you will be the guardian of our regulatory compliance strategy, ensuring that our innovative products navigate the complex landscape of US FDA regulations. You will lead the preparation of high-stakes submissions and collaborate with cross-functional teams to accelerate the time-to-market for life-changing medications.
Why Join Us?
- Competitive compensation and comprehensive benefits package.
- Opportunity to work on cutting-edge therapies with global impact.
- Professional development and leadership growth opportunities.
Key Responsibilities:
Responsibilities
- Lead the preparation, submission, and management of regulatory submissions to the US FDA, including NDAs, BLAs, and DMFs.
- Conduct thorough regulatory landscape analyses to identify trends and potential risks for the product portfolio.
- Ensure full compliance with 21 CFR Part 11, GxP guidelines, and international regulatory requirements.
- Manage the regulatory lifecycle for clinical trials and marketed products, ensuring timely renewals and updates.
- Collaborate with R&D, Quality Assurance, and Clinical Operations to resolve regulatory issues and provide strategic guidance.
- Act as the primary point of contact with health authorities and external regulatory consultants.
Qualifications:
Qualifications
- Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Bachelor’s degree in Pharmacy, Biology, Chemistry, or related scientific field; Master’s degree preferred.
- Deep understanding of FDA regulations, the New Drug Application (NDA) process, and post-approval commitments.
- Proven track record of managing complex regulatory dossiers independently.
- Excellent written communication skills with the ability to articulate complex scientific and regulatory concepts clearly.
- Strong project management skills with the ability to prioritize multiple high-priority deadlines.