Lupin Pharmaceuticals (Company Headquarters)

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.

This listing is sourced directly from Lupin Pharmaceuticals (Company Headquarters)'s careers page and normalized into a canonical job model.