Anywhere
Posted on November 11, 2023

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:

ANDA/ANDS Submission:
- Hands-on experience in the preparation, review, and submission of ANDA/ANDS in the US market, including Modules.
Life Cycle Management:
- Experience and knowledge of life cycle management for products filed in the US/Canada market.
Regulatory Guidelines:
- Stay updated with comprehensive knowledge of regulatory guidelines and requirements.
Cross-Functional Collaboration:
- Provide necessary regulatory inputs to cross-functional teams during various stages of product development and manufacturing.
Understanding US Regulatory Requirements:
- Be responsible for understanding requirements related to US regulatory submissions.
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.