Assistant Manager / Manager Regulatory Affairs – Complex Products

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.

UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

Assistant Manager / Manager Regulatory Affairs –

R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.

The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.

Essential skills and experience:

505(b)(2) NDAs, Hybrid Applications, IND submissions, and complex drug approvals.

. Specifically, the incumbent will be responsible for:

• Preparation and Submission of Pre-IND meetings Request and Packages and IND/NDA submissions ensuring compliance with FDA & EMA.
• Define nonclinical and clinical study requirements for 505(b)(2), including bridging studies.
• CTD dossier preparation (Modules 1-5) and CMC document review.
• Address comparability studies, bioequivalence challenges, and formulation complexities.
• Manage post-approval variations, renewals, and compliance updates.
• Engage in EMA scientific advice meetings and FDA Pre-IND consultations.

Required Skill:

• Expertise in 505(b)(2), IND/NDA/Hybrid Applications, and CMC compliance for US/EU.
• Strong knowledge of EMA/FDA guidelines, clinical trial regulations, and GMP standards.
• Experience with eCTD submissions, CMC documentation, and regulatory risk mitigation.
• Familiarity with eCTD software’s for regulatory submissions.
• Experience on the labeling updates required for complex product for 505b2.
• Experience on Pediatric Study Plan Submission and Approval, Post approval Study Requirements
• Experience on PDUFA Fees Requirements and Waiver Applications

Preferred Education requirements:

Bachelor’s/master’s in pharmacy, or Regulatory Affairs.

Candidate having Certifications in Regulatory Compliance or Drug Development Clinical Studies preferred.