Job Number: 9282
The Senior Director of Regulatory Affairs will be the primary point of contact for all interactions for the client with the FDA and with the Office of Generic Drugs. By maintaining positive interaction with regulatory agencies, the successful candidate will achieve regulatory submissions and approvals in support of the Company's business plans.
Provide strategic regulatory support to all functional groups.
Develop a strong relationship with the FDA.
Advise the team on bioequivalence/clinical strategies for more complex generic formulations.
Monitor and communicate new regulatory requirements and/or review trends to affected functional areas such as R&D, Quality, Operations, Sales and Marketing
Provide regulatory input on selection of products for development
Assess project risks, and where appropriate, recommend possible contingency plans and strategies to management in order to mitigate regulatory risks
Lead the creation, organization and management of the preparation of all types of FDA submissions including post approval changes and PLAIRs.
Lead the preparation and submission of the requisite Annual Reports, and PADERS for approved ANDA's.
Respond to queries from FDA.
Advise the Company on relevant new and existing regulatory strategies, risks and compliance requirements and provide regulatory expertise, advice and support for ANDA submissions.
Assess and justify the appropriate category for post-approval change classifications.
Foster collaborative, efficient and effective working relationships with internal team in India and the US.
Provide guidance, advice and training to junior staff members.
Ability to travel to parent company in India occasionally
Ability to participate in company external growth projects through contribution to due diligence and evaluation of opportunities.
Work closely with the Chief Commercial Officer, Supply Chain team and Finance team on a day to day basis as part of senior management team.
Knowledgeable in US regulatory laws and practices to able to advise the Company on relevant new and existing regulatory strategies, risks and compliance.
- Experience in submission of and approval of ANDAs and supplements; maintaining approved ANDAs in compliance with guidance to research and operations professional staff.
- Experience in preparation and submission of NDA 505(b)(2).
- Supervise/train 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.
- Knowledge of regulations/best practices for Rx drug storage/distribution including familiarity with the upcoming track and trace/ePedigree requirements.
Minimum M.S. In scientific discipline
At least 10 years of experience in the pharmaceutical industry including seven 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.