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
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.
- 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
- Regulatory Affairs
- ANDA/ANDS Submission
- Life Cycle Management
- Cross-Functional Collaboration
- Regulatory Guidelines
- Document Review
How to Apply
To apply for this job email your details to email@example.com