The Manager of Regulatory Affairs will lead the regulatory strategy and submission processes for Chemistry, Manufacturing, and Controls (CMC) associated with Abbreviated New Drug Applications (ANDAs) and generic products. This role requires a deep understanding of regulatory requirements, strong project management skills, and the ability to collaborate effectively with cross-functional teams.
Key Responsibilities:
- Develop and implement regulatory strategies for CMC components of ANDAs and generics.
- Stay updated on regulatory guidelines and industry trends related to CMC.
- Prepare, review, and submit CMC sections of ANDAs and amendments in compliance with FDA regulations.
- Coordinate with internal stakeholders to ensure timely and accurate submission of documents.
- Collaborate with R&D, Quality Assurance, Manufacturing, and other departments to ensure alignment on regulatory requirements.
- Provide regulatory guidance during product development, manufacturing, and quality control processes.
- Ensure compliance with all applicable regulations and internal policies.
- Conduct gap analyses and implement corrective actions as necessary.
- Liaise with the FDA and other regulatory bodies regarding CMC submissions and inquiries.
- Prepare responses to regulatory questions and deficiencies.
- Provide training and mentorship to junior regulatory staff.
- Foster a culture of regulatory awareness and compliance within the organization.
Qualifications:
Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (Master’s, Ph.D.) preferred.
Experience:
- Minimum 5 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on CMC.
- Proven experience with ANDA submissions and knowledge of generic drug development.
Skills:
- Strong knowledge of FDA regulations and guidance related to CMC and ANDA submissions.
- Excellent project management and organizational skills.
- Strong analytical and problem-solving abilities.
- Exceptional written and verbal communication skills.
