Title:  Manager, Regulatory Affairs

Date:  Aug 11, 2022
Location:  Hawthorne, New York
Company:  Taro Pharmaceutical USA Inc

Taro is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. Providing quality products through scientific innovations, diligence and precision is the goal of all of Taro's research programs. Taro develops, manufactures and markets prescription and over-the-counter pharmaceutical products primarily in the United States, Canada and Israel.

 

This position is based out of our Hawthorne, New York office in the picturesque Hudson Valley located in Westchester County. The Hudson Valley is rich with history and culture and is the closest county to New York City.  With a mixture of urban and city life, Westchester country is full of places to see and things to do. With great hotels, Michelin-rated dining and tons of outdoor activities, you’ll find a community of amazing people whose talents are as widespread as Westchester County’s 500 square miles.

 

Responsible for leading, coordinating and prepare 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. To lead and to guide a team of Regulatory Associates

 

Duties and responsibilities

 

  • 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.

 

Qualifications

 

  • MS in Life Sciences and minimum 3-4 years managing regulatory team in the generic pharmaceutical industry.

  • 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.

 

Qualifications

  • 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.

 

 

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 the employer 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).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that 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, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

 

Notice to Agency and Search Firm Representatives:

Taro Pharmaceuticals (Taro) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.