Regulatory Affairs Senior Manager

Responsibilities

• Communicate and follow-up status with FDA for 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.
• Prepare, 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 a 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.
• Prepare, 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 file 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 control correspondence.
• Maintain awareness of new and/or updated guidance from FDA websites 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.
• Participate 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 the performance of the individuals in the department.
• Cook up coordination with global and local affiliates.