Am / Manager Regulatory Affairs Complex Products (us And Europe)
- Umedica Labs
- 10 - 15 years
- Mumbai
- 15 days ago
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Job Description
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.
As part of our further expansion and growth plans, we are looking to hire Assistant Manager / Manager Regulatory Affairs Complex Products an aggressive / dynamic Regulatory Affairs Professional.
This position is based at our R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.
The remuneration package will be commensurate with the incumbents professional experience and will be in line with market standards.
Essential skills and experience:
The incumbent must have min. 10+ years experience in the pharmaceutical industry with a minimum of 10-12 years experience handling Regulatory compliance across the US, European and UK market specializing in 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 softwares 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:
Bachelors/masters in pharmacy, or Regulatory Affairs.
Candidate having Certifications in Regulatory Compliance or Drug Development Clinical Studies preferred.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Research & Development - OtherRole: Research & Development - OtherEmployement Type: Full timeContact Details:
Company: Umedica LabsLocation(s): Mumbai
Keyskills: Regulatory Affairs
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