Biocon Job Opening: Formulation Regulatory Affairs Professionals

Biocon Recruitment Notification
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Company Name: Biocon Limited

Welcome to Biocon Limited, a globally renowned biopharmaceutical company committed to delivering affordable healthcare solutions. With a legacy of innovation and excellence, Biocon has emerged as a leader in the industry. Our dedication to advancing healthcare is reflected in our diverse portfolio, cutting-edge research, and a dynamic team of professionals.

Company Vacancies List

Position Title: Assistant Manager/Deputy Manager – Formulation Regulatory Affairs

Job Description

As an Assistant Manager/Deputy Manager in Formulation Regulatory Affairs for the US market, you will:

  1. ANDA/ANDS Submission:
    • Hands-on experience in the preparation, review, and submission of ANDA/ANDS in the US market, including Modules.
  2. Life Cycle Management:
    • Experience and knowledge of life cycle management for products filed in the US/Canada market.
  3. Regulatory Guidelines:
    • Stay updated with comprehensive knowledge of regulatory guidelines and requirements.
  4. Cross-Functional Collaboration:
    • Provide necessary regulatory inputs to cross-functional teams during various stages of product development and manufacturing.
  5. Understanding US Regulatory Requirements:
    • Be responsible for understanding requirements related to US regulatory submissions.
  6. Document Review:
    • Review technical (developmental and plant) documentations required for dossier submission.

Experience Requirement:

  • 6 to 12 years of relevant experience.

Detailed Job Description

  • Role: Assistant Manager/Deputy Manager – Formulation Regulatory Affairs
  • Industry Type: Biopharmaceuticals
  • Department: Regulatory Affairs
  • Employment Type: Full Time
  • Role Category: R&D

Key Skills

  • Regulatory Affairs
  • ANDA/ANDS Submission
  • Life Cycle Management
  • Cross-Functional Collaboration
  • Regulatory Guidelines
  • Document Review

How to Apply

Candidates with the relevant experience are invited to share their profiles at or

Biocon Recruitment Notification
Biocon Recruitment Notification

To apply for this job email your details to

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