(Senior) Regulatory Affairs Consultant managing regulatory submissions for various clients at Parexel. Collaborating with stakeholders and ensuring high - quality work for client satisfaction.
About the role
- Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with FDA expectations and global standards
- Prepare and review technical regulatory documents to submit to regulatory authorities, including the FDA, to support lifecycle management of established vaccines
- Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance to ensure compliance with U.S. regulatory requirements, including Good Manufacturing Practices (GMPs)
- Serve as Point of Contact for the FDA to receive and respond to general inquiries, notifications, and requests for information, as well as to lead discussions in formal meetings and other engagements with the Agency
- Identify risks and propose mitigation strategies to ensure smooth regulatory processes
- Mentor and train team members, fostering a culture of continuous improvement
Requirements
- Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field
- 6+ years of experience in CMC regulatory affairs, with a focus on IND and BLA submissions to the FDA
- Experience as a liaison for FDA communications
- Experience with FDA regulations, including 21 CFR, ICH guidelines, and GMP/GDP requirements related to biologics
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
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