Job Description
ApexBio Therapeutics is a leading biotechnology firm dedicated to discovering and developing innovative therapies for unmet medical needs. We are seeking a highly motivated and strategic Senior Regulatory Affairs Manager to join our elite regulatory team. In this pivotal role, you will lead the strategic planning and execution of global regulatory submissions, ensuring our groundbreaking candidates navigate the complex pathway to market efficiently and compliantly. You will work at the intersection of science and policy, collaborating with cross-functional teams of scientists, clinicians, and legal experts to drive our pipeline forward.
Why Join Us?
- Competitive salary and comprehensive benefits package.
- Work in a state-of-the-art facility in the heart of Boston’s biotech hub.
- Opportunity to impact global healthcare through cutting-edge therapies.
- Professional development and mentorship opportunities.
If you are a results-oriented leader with a passion for regulatory compliance and a desire to shape the future of medicine, we want to hear from you.
Responsibilities
- Lead Regulatory Strategy: Orchestrate the regulatory strategy for all development programs, including Investigational New Drug (IND) submissions, New Drug Applications (NDA), and Biologics License Applications (BLA).
- Submission Management: Direct the preparation, review, and submission of regulatory dossiers to the FDA and international health authorities (EMA, PMDA, etc.) with a focus on speed and accuracy.
- Stakeholder Liaison: Serve as the primary point of contact for health authorities and regulatory agencies, managing relationships and responding to inquiries.
- Compliance Oversight: Ensure all activities remain in strict compliance with cGMP, 21 CFR Part 11, and other relevant regulatory standards.
- Change Management: Monitor and interpret new regulatory guidelines, legislation, and trends to advise internal leadership on necessary operational changes.
- Team Leadership: Mentor junior regulatory affairs staff, fostering a culture of continuous improvement and regulatory excellence.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field; Master’s degree preferred.
- Experience: Minimum of 7-10 years of experience in pharmaceutical or biotechnology regulatory affairs, with at least 3 years in a leadership or management capacity.
- Technical Expertise: In-depth knowledge of FDA regulations (21 CFR Parts 312, 314, 601) and EMA guidelines.
- Project Management: Proven track record of successfully managing complex regulatory submissions and timelines.
- Communication: Exceptional written and verbal communication skills, with the ability to convey complex regulatory concepts to diverse audiences.
- Technical Skills: Proficiency in regulatory submission software and document management systems.