For The Candidates

• Responsible for the preparation and submission of IND/CTA and maintenance, in compliance to regulations, for the assigned project(s)
• Responsible for all day-to-day regulatory submissions to FDA for the assigned project(s)
• Responsible for providing strategic regulatory support to the assigned project(s)
• Responsible for overseeing the Regulatory CRO(s) for ex-US regulatory submissions of the assigned project(s)
• Responsible as Regulatory lead in the preparation of NDA
• Responsible for post-approval maintenance of NDA

Essential Job Responsibilities/Primary Activities

• Prepare and ensure quality day-to-day submissions to FDA within timeline (IND Amendments, Safety Reports, etc.)
• Draft the cover letters of FDA correspondence, meeting request, meeting briefing package, etc.; ensure proper review, finalization and timely submission of the documents
• Prepare and submit IND/CTA; ensure maintenance of IND, in compliance to regulations, for the assigned project(s)
• Orchestrate the preparation, review, and timely submission of IND annual reports
• Oversee the Regulatory Specialist and Administrative Assistant helping in the preparation of all types of regulatory submissions and maintenance of tracking of the submissions
• Work with the regional team for the planning of regulatory submissions including defining timeline
• Interact with the global team to collect the document components required for regulatory submissions
• Provide clarification or guidance to the team on the strategic regulatory issues; provide interpretation of the regulations to support/enhance team?s understanding on the regulatory requirements
• Keep the team(s) updated on the recent FDA initiatives and evolving therapeutic area-specific regulatory requirements
• Represent the RA functional area in the NDA preparation team and accomplish the assigned regulatory tasks including drafting of submission components such as labeling
• Interact/manage internal resource or external vendors preparing the eCTD IND or NDA
• Maintain the approved NDA in compliance with the regulations
• Assist in the preparation and conduct of meetings with the FDA
• Contribute to the review of internal SOPs and policies
• Performs other departmental duties as assigned

Qualifications

• Degree

Required:  Bachelors

 Preferred:  B.S (life science); Regulatory Affairs Certification (RAC)

5+ years of drug regulatory experience; in-depth knowledge of US regulations; prior experience in IND submission of new chemical entity (NCE), hands-on experience in preparation of different types of regulatory submissions, eCTD NDA submission experience is a plus; advanced MS Office skills (Word, Excel, Powerpoint); Proficiency with Adobe Acrobat to create and collate documents; excellent verbal and written communication skills

Additional Information

• Ability to think strategically and develop regulatory strategy for product development programs
• Ability to interact with external consultants in strategy development sessions
• Ability to work cohesively with a cross-cultural global development team
• Ability to handle multiple priorities and mange time-line in a fast-pace environment