Regulatory Affairs Senior Manager

Responsibilities

• Serve as 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.
• Prepare, review, and file new ANDA, NDA, IND and DMF for the U.S. FDA in eCTD format.
• Prepare, review and file all post marketing activities, including timely submission of Annual Reports, CPP, and release of detained products at customs.
• 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, submit, and monitor 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, and 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, and status for pending and approved applications.
• Respond to FDA's requests expeditiously.
• Review and provide guidance for Citizen Petitions.
• Prepare, review and file suitability petitions and control correspondence.
• Monitor FDA websites for new and/or updated guidances 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.
• Actively participate in the Lessons 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.
• Coordinate with global and local affiliates.

Education and Experience

• MS in Life Sciences.
• 4-5 years of proven experience in working with the FDA and managing a 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.