Job Description
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our dynamic team in Boston. At ApexBio Therapeutics, we are dedicated to accelerating the development of groundbreaking therapies that improve patient outcomes worldwide. In this pivotal role, you will lead the strategic planning and execution of regulatory submissions, ensuring our innovative drug candidates meet the highest standards of safety, efficacy, and compliance.
As a key member of our Regulatory Affairs team, you will drive the regulatory strategy for our clinical pipeline, working closely with cross-functional teams including R&D, Clinical Operations, and Quality Assurance. If you are a results-oriented professional with a passion for regulatory science and a desire to make a tangible impact on the pharmaceutical industry, we want to hear from you.
Why Join Us?
- Competitive salary and comprehensive benefits package.
- Opportunity to work on cutting-edge biopharmaceutical projects.
- Professional development and mentorship opportunities in a collaborative environment.
- Flexible working arrangements and a commitment to work-life balance.
Responsibilities
- Lead the preparation, compilation, and submission of regulatory documents (IND, NDA, sNDA, MAA) to the FDA, EMA, and other health authorities.
- Manage the regulatory submission lifecycle, including response to agency inquiries and management of deadlines.
- Conduct thorough regulatory intelligence to identify changes in global regulations and incorporate them into the company's development plans.
- Liaise with internal stakeholders to ensure alignment between scientific data and regulatory requirements.
- Mentor junior Regulatory Affairs staff and provide training on regulatory processes and best practices.
- Oversee the management of regulatory documentation libraries and ensure compliance with document control standards (e.g., 21 CFR Part 11).
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Chemistry, Pharmacology, or a related field required; PhD preferred.
- Minimum of 5-7 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Strong working knowledge of FDA regulations (21 CFR) and ICH guidelines (e.g., ICH E6, E8, E9).
- RAC (Registered Availability Consultant) certification is highly desirable.
- Proven track record of successfully managing complex regulatory submissions and interactions with health authorities.
- Excellent written and verbal communication skills, with the ability to present complex regulatory information clearly.
- Strong project management skills and the ability to prioritize multiple competing deadlines.