Lupin Pharmaceuticals (Company Headquarters)
Senior Director, Regulatory Affairs (Inhalations – ANDAs and 505 (b)(2))
Coral Springs, FL, US · Director
Sponsorship not specifiedDetected 132 days ago
Business DevelopmentFDA RegulatoryMedical DevicesResearchCommunicationWritingRegulatory Affairs
About the role
- Overview Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions.
- Together these entities make up the generic and branded U.S. business.
- Lupin has a significant generic pipeline, and a branded focus on women's health.
Responsibilities
- The Senior Director will build solid, effective relationships with peers and staff from other regional and functional regulatory bodies to develop US submission strategies and provide support as needed.
- The candidate will get involved in the early stages of product development to ensure that the ANDAs with good experience in Complex Products have sufficient information to support a quicker approval.
- Further, it supports all the Regulatory aspects of the Company's generic businesses.
Requirements
- This position supervises Regulatory personnel as required.
Company info
- All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin.
- Lupin is prided on being people-focused and centered around how impactful we are with our customers.
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