Job Number: 9171
Responsible for managing and guaranteeing the processes of maintenance and registration of new products and state wholesaler licenses as required from the FDA (Food and Drug Administration) and other regulatory agencies.
Provide strategic regulatory support to all functional groups.
Create, organize and manage the preparation of all types of FDA submissions including post approval changes and PLAIRs.
Preparation and submission of the requisite Annual Reports, and PADERS for approved ANDA's.
Respond to queries from FDA.
Develop a strong relationship with the FDA.
Advise the Company on relevant new and existing regulatory strategies, risks and compliance requirements and provide regulatory expertise, advice and support for ANDA, NDA 505(b)(2) submissions.
Assess project risks, and where appropriate, recommend possible contingency plans, and strategies to management in order to mitigate regulatory risks
Assess and justify the appropriate category for post-approval change classifications.
Advise the team on bioequivalence/clinical strategies for more complex generic formulations.
Independently review and provide feedback to the marketing and business development team. Provide regulatory input on selection of products for development
Foster collaborative, efficient and effective working relationships with internal team in India and the US.
Provide guidance, advice and training to junior staff members.
Monitor and communicate new regulatory requirements and/or review trends to affected
functional areas such as R&D, Quality, Operations, Sales and Marketing
At least 10 years of experience in the pharmaceutical industry including 7 plus years regulatory affairs experience in both pre and post approval pharmaceutical FDA submissions.
Knowledge of filing and approval process for generic drug products.
Experience in dealing with the FDA OGD is desirable.
Experience writing and assembling the supporting documentation for ANDAs and other regulatory filings, including familiarity with CTD format and eCTD submissions.
Knowledge of product development milestones and compliance requirements.
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
High degree of motivation and initiative are required.
Proven ability to anticipate challenges and negotiate through them to achieve desired outcome.
Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
Excellent communication, verbal and written English skills and ability to/experience of work across cultures and time zones.
Ability to work successfully within a team/collaborative environment with a high level of professionalism and with the parent company personnel in India.
Proficient with Adobe, eCTD software and Microsoft Office applications.
Experience in submission of and approval of ANDAs and supplements; maintaining approved ANDAs in compliance with guidance to research and operations professional staff.
Train junior regulatory professional staff to improve their knowledge and performance.
Thorough understanding of ICH and FDA guidelines
Strong understanding of R&D processes required for ANDA submissions.