We are currently seeking a Regulatory Affairs Manager who will be responsible for leading, coordinating, and preparing a wide variety of drug product registration activities including U.S. ANDA, NDA, IND, DMF submissions and their associated regulatory correspondence. Additionally, the Manager of Regulatory Affairs will communicate with the FDA for all regulatory issues/questions, provide regulatory guidance to internal constituents, and lead and guide a team of Regulatory Associates.
- Preparation, Review, and filings of new ANDA, NDA, IND, and DMF for the U.S. FDA in eCTD format.
- Preparation, Review, and filing of all post-marketing activities which include, timely submission of Annual Reports, CPP, release of detained products at customs etc.
- Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions.
- Provide regulatory guidance to R&D, Technical Operations Sales and Marketing, Quality, Clinical, Legal.
- Supervise, prepare and submit drug product labeling generation and monitor changes (Rx and OTC). Strong OTC background is critical.
- Contact FDA and participate in Pre-IND and Pre-NDA meetings. Prepare, review and filing of the package for these meetings.
- Communicate and follow-up with FDA for any issues, responses, status for pending and approved applications. Respond to FDA’s request expeditiously.
- Review and provide guidance for Citizen Petitions. Prepare, review and file suitability petitions and controlled correspondence.
- Monitor FDA websites for new and/or updated guidance’s and implement and guide the team, as required.
- Review, approve and file any promotional or advertising material when required.
- Review and approve all change controls from manufacturing sites, when required.
- Maintain all documents on approved and filed products.
- Supervise Regulatory Affairs Associates
- Participate in decision making process with other applicable departments.
- Prepare and evaluate performance of the individuals in the department.
- Coordinate with global and local affiliates.
Experience & Skills Required
- Minimum of 3-4 years regulatory experience in the generic pharmaceutical industry.
- Supervisory experience required.
- Strong background in CMC aspects of drug product registration, knowledge of U.S. drug registration (NDA, ANDA, DMF & INDs) and with U.S. drug product labeling requirements.
- Excellent verbal/written communication skills, computer skills and attention to detail.
- Excellent teamwork abilities.
- Work extended hours as required on time sensitive projects to achieve deadlines.
- Travel for FDA meetings, global conferences
- Multitask in a fast paced working environment meeting demands of multiple requests from FDA