• 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.
  
  

• 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.

• 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.
  
  

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