Lupin Pharmaceuticals - Franklin Township, NJ

posted 4 months ago

Full-time - Mid Level
Remote - Franklin Township, NJ
Merchant Wholesalers, Nondurable Goods

About the position

The Manager of Regulatory Affairs at Lupin Pharmaceuticals will oversee existing REMS programs and assist in the development of new REMS initiatives. This role requires collaboration with various departments to ensure compliance with FDA regulations and effective management of regulatory submissions. The position reports to the Associate Director of Regulatory Affairs and involves significant interaction with cross-functional teams.

Responsibilities

  • Manage Lupin's existing REMS programs and assist in the development of new REMS programs as needed.
  • Analyze FDA requirements related to REMS and patient safety programs.
  • Collaborate with Pharmacovigilance, Commercial Operations, Finance, and Legal in managing REMS Programs.
  • Review and approve REMS program deliverables.
  • Monitor and report on the progress of program launches and operations, identifying risks and issues.
  • Participate in the evaluation and selection of REMS vendors according to procurement policies.
  • Review ANDAs, supplements, and amendments, highlighting major gaps in submission documents.
  • Independently manage business development product applications and prepare CMC/labeling documents for registration submissions.
  • Conduct trend analysis of received deficiencies and provide CMC strategy throughout the product lifecycle.
  • Independently review, compile, and submit high-quality controlled correspondences and meeting requests.
  • Manage product distribution licenses and highlight regulatory changes impacting commercial operations.
  • Maintain and update regulatory databases for accuracy.

Requirements

  • 3 years of experience in product development and risk management.
  • 1 year of experience with REMS programs.
  • Strong knowledge of FDA regulations and guidance regarding REMS.
  • Experience in CMC and labeling aspects of regulatory submissions.
  • Proficiency in Microsoft Excel, Word, and PowerPoint.
  • Excellent verbal and written communication skills.
  • Ability to work in a complex, matrix environment and with cross-functional teams.

Nice-to-haves

  • Experience in reviewing, authoring, or managing components of regulatory submissions.
  • Hands-on experience with eCTD publishing tools.
  • Advanced computer skills and ability to conduct research online.

Benefits

  • Health insurance
  • Dental insurance
  • Vision insurance
  • 401(k)
  • Paid time off
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