Biocon Job Opening: Formulation Regulatory Affairs Professionals
- Company Vacancies List
- Position Title: Assistant Manager/Deputy Manager – Formulation Regulatory Affairs
- Job Description
- Experience Requirement:
- Detailed Job Description
- Key Skills
- How to Apply
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.
