Biocon Job Opening: Formulation Regulatory Affairs Professionals

Company Name: Biocon Limited
Website: www.biocon.com

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 rashmi.gupta@biocon.com or upendra.kamma@biocon.com.