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Associate Director, Regulatory Affairs (CMC) - Hawthorne, NY

Print Home » Associate Director, Regulatory Affairs (CMC) - Hawthorne, NY
Taro in USA
JOB TITLE: Executive 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
Associate Director Regulatory Affairs (CMC) is responsible for the preparation of various regulatory submissions and the supervision of chemistry staff.
1. Responsible for overseeing preparation, compilation, review and submission of new NDAs, ANDAs, ANADAs, DMFs and INDs in eCTD format in accordance with ICH, CFR and current Regulatory Guidance for FDA submission./div>
2. Communicate with FDA for Chemistry issues on both pending and approved applications.
3. Coordinate efforts and supervise Chemistry group to ensure company projected deadlines are met.
4. Respond to deficiencies related to Chemistry, Bioequivalence and Patents in a timely manner, submit controlled correspondence for Chemistry and bio requests.
5. Responsible for overseeing Post-Marketing activities which include, review and submission of Supplements (PAS, CBE-30, CBE), Annual Reports submission within the due dates, review of change controls and regulatory reporting assessment, Drug listing and PLAIR activities.
6. Review and approve Prototype formulation during early drug development stages to be in compliance with Inactive Ingredient Database, review product development reports based on FDA’s Quality by design and Quality based review requirements, provide regulatory guidance for compatibility studies and method validation reports, review of SBOA and citizen petitions, if required.
7. Oversee maintenance of comprehensive electronic lists for deficiencies received and respond. Oversee annual reports submissions, approved and pending ANDAs and NDAs and supplements submitted.
8. Facilitate release of detained shipment by providing End User letters, NDC numbers, Tariff and Product codes.
9. Serve as direct contact between broker and FDA to answer all customs release inquiries.
10. Prepare and revise all SOPs related to CMC and electronic filing.
11. Prepare and review documentation for SPL conversion of labeling to be submitted to FDA for Drug listing and resolve any validation issues.
12. Provide guidance of CMC requirements to R&D during early drug development stage, QA and QC for proposed changes to manufacturing and specification documents as required.
13. Keep abreast of all new regulatory guidelines and regulations. Notify the supervisor and all applicable departments of any new updates.
14. Compile and submit packages for Pre-IND and Pre-NDA meetings with FDA for New Drugs.
15. Provide guidance and advise management regarding improvements in CMC harmonization process of regulatory documentation at all manufacturing sites.
1. Decision making ability when representing regulatory as designated.
2. Provide strategies and guidance to other Taro departments as required.
3. Evaluate and review direct reports’ performance.
4. Provide training to the direct reports and educate them of current regulations and guidance.
5. Represent Regulatory Head in meetings and discussions as designated.
6. Provide regulatory guidance to R&D, Clinical, QA and QC as required.
7. Respond to FDA in person during inspections, and face to face meetings, and respond to other FDA correspondences via phone, fax, e-mail etc.
1. Bachelor's or Masters degree in scientific field; advanced degree preferred.
2. Minimum 5 years regulatory CMC experience in the generic pharmaceutical industry.
3. Advanced computer skills required.
4. Strong verbal/written communication skills and the ability to work independently in preparation of regulatory documents and correspondence.
5. Current knowledge of CFR, USP, ICH and Regulatory Guidance.
6. Knowledge of drug development and post approval maintenance activities.
7. Detail oriented and good understanding of Chemistry batch records, ability to identify deficiencies and inconsistencies in documents.
Traveling required when participating in FDA Conferences, Due Diligence activities and Global meetings within Taro affiliates. Minimum of 8 hours per day, with extended hours, as required.
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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