Manager/Sr. Manager

3 days ago

Navi Mumbai, Maharashtra, India Umedica Labs Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Role & responsibilities

  • Regulatory Submissions:

  • Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA

  • Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports)

  • Ensure compliance with current USFDA regulations and guidance documents

  • FDA Interactions:

  • Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings)

  • Participate in and support FDA meetings as the regulatory lead

  • Handle Controlled Correspondence with the FDA for product development and regulatory strategy

  • Product Expertise:

  • Provide regulatory support for complex formulations, including injectables and liquid dosage forms

  • Collaborate with R&D, QA, QC, and manufacturing teams to ensure regulatory alignment throughout the product lifecycle

  • Leadership & Communication:

  • Lead a team of regulatory professionals, providing guidance, training, and performance management

  • Communicate effectively with internal stakeholders and external regulatory bodies

Preferred candidate profile

  • Masters degree in Pharmacy
  • 12–15 years of experience in US Regulatory Affairs with a proven track record in ANDA/NDA submissions
  • Hands-on experience with FDA meetings, Controlled Correspondence, and post-approval changes
  • Strong understanding of injectables, liquid dosage forms, and complex generics
  • Excellent written and verbal communication skills
  • Demonstrated leadership and team management capabilities

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