Job Description – AD/Dir Regulatory Affairs

Reports To:   SR Director- Regulatory Affairs.

·           Prepare and review various modules of ANDAs,  and responses to FDA queries.

·           Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for ANDA’s.

·           Hands-on work experience on eCTD modules 1, 2, 3 and 5 is required.

·           Proven ability to manage competing priorities and multiple filings in a dynamic environment is required.

·           In-depth knowledge and experience of regulatory CMC documents review, and approval is required.

·           Provide regulatory guidance to cross functional teams on product development, manufacturing, testing and commercialization of various complex drug products and dosage forms.

·           Stay current and proactively implement new regulations published by the US FDA

·           Establish and maintain effective internal and cross-functional team communications i.e. provide regular feedback and communicate work challenges/issues and successes.

·           Maintenance of Electronic Submissions Gateway account and eCTD software

·           eCTD compilation experience is preferred.

·           Any other work assigned by the supervisor.

Requirements and Qualifications:

·           Bachelor’s degree with 8 plus years’ experience in regulatory strategy and filing of ANDA’s, in a pharmaceutical Industry.

·           Hands on experience of using any e-CTD build software.

·           Ability to multi-task in a fast-paced environment with minimal supervision.

·           Ability to work flexibly, organize own workload and effectively manage competing priorities.

·           Excellent attention to detail and accuracy maintaining consistently high-quality standards.

·         Ability to establish and maintain effective working relationships with coworkers, managers and clients.

·           Willingness to learn new skills and flexibility to support business needs

·           Apply knowledge and expertise, to contribute to and provide solutions to process improvements.