Associate Director, Regulatory Affairs

Found in: Jooble US O C2 - 2 weeks ago

New York State, United States Alternative Resources Company Full time

Associate Director, Regulatory Affairs

This position will serve as the company US Agent and a contact point between the FDA and company sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Senior Regulatory Associates managing, preparing and filing of wide variety of regulatory submissions and their associated regulatory correspondences. Overseeing and supervising of State licensing activities.

Responsibilities

  • US Agent for all products, responsible for communication between the FDA and manufacturing sites.
  • Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications
  • Lead, guide and train the CMC team to ensure highly qualified personnel that can perform to meet company KPO
  • 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.
  • Respond to deficiencies related to Chemistry, Bioequivalence and Patent in timely manner.
  • Review and approve Prototype formulation during early drug development stages to be compliant with Inactive Ingredient Database and FDA guideline.
  • Review and submit Controlled Correspondences related to product under development.
  • Preparation, submission and monitoring of PLAIR activities, prior to new product launch
  • 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.
  • 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 and approve all change controls from manufacturing sites, when required.
  • Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing sites.
  • Active participation in Lesson learned process, derived from regulatory correspondences.
  • Support TA Labeling team, when required
  • 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.

Qualifications

  • MS in Life Sciences
  • 5-7 years of proven experience in working with the FDA and 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.
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