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Senior Director, Regulatory Affairs - Hawthorne, NY

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Taro in USA
JOB TITLE: Senior Director, Regulatory Affairs
DEPARTMENT: Regulatory Affairs (RA)
REPORTS TO: Global Vice President, R&D
DIRECT REPORTS: Associate Director, RA (Labeling -1 and CMC -1); Manager, Drug Safety; Administrative Assistant
Responsible for leading and coordinating a wide variety of drug product registration activities including U.S. ANDA, NDA, IND, DMF submissions and their associated regulatory correspondence. Communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents.
1. Oversee preparation and filings of ANDA, NDA, IND and DMF for the U.S. FDA in both eCTD and paper formats.
2. Oversee all post marketing activities which include, timely submission of Annual Reports, Adverse Event reports, Annual and Quarterly periodic report, CPP, MSDS, release of detained products at customs etc.
3. Manage regulatory correspondence mainly to CDER, FDA, OPDP, CVM, User fee staff, drug listing and Board of Pharmacies for state licensing submissions.
4. Provide regulatory guidance to R&D, Technical Operations Sales and Marketing, Quality, Clinical, Legal and Drug Safety.
5. Supervise drug product labeling generation and monitor changes (Rx and OTC).
6. Oversee Pharmacovigilance activities such as timely submission of 15-Day Alert Reports, signaling and trending activities, processing of Complaints related to adverse events, providing responses to Medical Inquiries regarding drug usage and safety concerns, reconciliation activities and interaction with Global PV team for issues related to Drug Safety.
7. Develop and maintain SOPs needed for Pharmacovigilance Practices.
8. Contact FDA and participate in Pre-IND and Pre-NDA meetings. Oversee preparation of the package for these meetings.
9. Communicate and follow-up with FDA for any issues, responses, status for pending and approved applications. Respond to FDA’s request expeditiously.
10. Review and provide guidance for Citizen Petitions. Supervise filing requirement for suitability petitions and controlled correspondence.
11. Provide regulatory guidance and strategies to R&D during initial stages of Drug Development Plans.
12. Review Drug Safety and Quality agreements with third party for related areas.
13. Review Standard Operating Procedures, Drug Safety and Quality agreements with third party for related areas.
14. Monitor FDA websites for new and/or updated guidances and implement as required.
15. Review, approve and file any promotional or advertising material when required.
16. Review and approve all change controls from manufacturing sites when required.
17. Maintain all documents on approved and filed products.
18. Handle FDA inspection and prepare responses to observations.
1. Participate in decision making process with other applicable departments.
2. Prepare departmental budget.
3. Prepare and evaluate performance of the individuals in the department.
4. Provide regulatory recommendations and strategies in due diligence activities.
5. Coordinate with global and local affiliates.
1. MS or Ph.D. in Life Sciences and minimum 5-7 years regulatory experience in the generic pharmaceutical industry. Supervisory experience required.
2. Expertise in CMC aspects of drug product registration, knowledge of U.S. drug registration (NDA, ANDA, DMF & INDs) and familiarity with U.S. drug product labeling requirements.
3. Excellent verbal/written communication skills, computer skills and attention to detail.
1. Work extended hours as required on time sensitive projects to achieve deadlines.
2. Travel for FDA meetings, global conferences with affiliates for harmonization, and due diligence activities.
3. Multitask in a fast paced working environment meeting demands of multiple requests from FDA.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude Taro Pharmaceuticals from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
Taro Pharmaceuticals provides equal employment opportunities for all current employees and applicants for employment. No one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, sexual orientation, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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