JOB DESCRIPTION
Responsible for assisting the Regulatory Team with 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.
Responsibilities:
- Provide regulatory support to all functional groups.
- Submit electronic documentation through the ESG (Electronic Submissions Gateway).
- Create, organize and coordinate the preparation of FDA submissions including post approval changes and PLAIRs (Pre-Launch Activities Importation Requests).
- Participate in the preparation and submission of the requisite Labeling update, Annual Reports, and PADERs (Periodic Adverse Drug Experience Reports) for approved ANDA's.
- Respond to queries from FDA.
- Assist with Pharmacovigilance, Product Complaints and Medical Information function for the U.S. Generics business.
- Ensure company is in compliance with licensing requirements for business in the states, for its warehousing activities as well as other mandatory drug licensing requirements.
- Foster collaborative, efficient and effective working relationships with internal team in India and the US.
- Monitor and communicate new regulatory requirements and/or review trends to affected functional areas such as R&D, Quality, Operations, Sales and Marketing.
- Review product despositions and verify incoming shipments and release as necessary
- Additional responsibilities may be assigned as appropriate.
Desired Skills:
- Experience in submission of and approval of ANDAs and supplements; maintaining approved ANDAs in compliance with guidance to research and operations professional staff.
- Understanding of ICH and FDA guidelines
- 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/ePedigreee requirements.
Requirements:
- Minimum B.S. in scientific discipline, M.S. preferred.
- At least 5 years of experience in the pharmaceutical industry including 3 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.