Job Description
Join a mission-driven team at the forefront of medical innovation.
About the Role:
We are seeking a highly skilled and detail-oriented Senior Regulatory Affairs Specialist to join our dynamic regulatory team in Cambridge, MA. In this pivotal role, you will be responsible for navigating the complex landscape of global pharmaceutical regulations, ensuring the successful submission and approval of our groundbreaking therapeutics. You will work closely with cross-functional teams of scientists, clinicians, and business operations to bring life-changing medicines to patients faster.
Why Join Us?
- Work with cutting-edge technologies and high-impact projects.
- Competitive compensation package and comprehensive benefits.
- Flexible work environment with a focus on work-life balance.
Key Responsibilities:
- Lead the preparation and submission of regulatory documents, including INDs, NDAs, and BLAs to the FDA and international regulatory bodies.
- Manage the regulatory lifecycle for assigned product candidates, ensuring compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
- Monitor changes in global regulatory guidelines and interpret their impact on ongoing development programs.
- Collaborate with cross-functional teams to resolve regulatory inquiries and prepare responses to agency questions.
- Oversee the archiving and maintenance of regulatory dossiers and correspondence.
- Participate in internal training and regulatory strategy meetings to drive continuous improvement.
Qualifications:
- Master’s degree in Pharmacy, Biology, Chemistry, or related scientific field; Bachelor’s degree with significant relevant experience considered.
- Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Deep understanding of FDA regulations (21 CFR) and ICH guidelines.
- Proven track record of successfully managing regulatory submissions.
- Exceptional written and verbal communication skills with the ability to present complex technical data clearly.
- Strong project management skills and the ability to prioritize multiple deadlines in a fast-paced environment.
ApexBio Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Responsibilities
- Lead the preparation and submission of regulatory documents, including INDs, NDAs, and BLAs to the FDA and international regulatory bodies.
- Manage the regulatory lifecycle for assigned product candidates, ensuring compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
- Monitor changes in global regulatory guidelines and interpret their impact on ongoing development programs.
- Collaborate with cross-functional teams to resolve regulatory inquiries and prepare responses to agency questions.
- Oversee the archiving and maintenance of regulatory dossiers and correspondence.
- Participate in internal training and regulatory strategy meetings to drive continuous improvement.
Qualifications
- Master’s degree in Pharmacy, Biology, Chemistry, or related scientific field; Bachelor’s degree with significant relevant experience considered.
- Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Deep understanding of FDA regulations (21 CFR) and ICH guidelines.
- Proven track record of successfully managing regulatory submissions.
- Exceptional written and verbal communication skills with the ability to present complex technical data clearly.
- Strong project management skills and the ability to prioritize multiple deadlines in a fast-paced environment.