Biocon Limited Walk-in Interview 2023 .Biocon Limited Notification full details below.Interested and eligible candidates can attend Interview on scheduled time and venue.Our pioneering spirit paved the way for biotechnology in Bangalore, Hyderabad, Vishakhapatnam., and we continue to apply the same spirit in finding novel approaches to improve patient outcomes today for a better tomorrow. This drives us to continuously find new ways to treat diabetes, cancer and autoimmune diseases.
Vacancy details:
- Post Name: EXECUTIVE/ ASSISTANT MANAGER/SENIOR DIRECTOR/SENIOR MANAGER/MANAGER/SENIOR EXECUTIVE/SENIOR EXECUTIVE/ASSOCIATE
- Qualification: M.Sc/Bsc/ MA/ M.Com/BE
- Experienced:0-25 years
Job Description: Greeting from Biocon Limited !!!!!!
Important Details :
- Post of date:04/07/2023
- Location: India
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Role Summary
Key Activities:
Regulatory Strategy and Execution
• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
• Provide regulatory direction on global regulatory requirements to support product development
• Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
• Support development and execution of clinical/non-clinical strategies
• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
• With minimal supervision, participate in development of risk management and contingency planning
• Ensure and lead regulatory compliance for biosimilar products
• Participation in regulatory meetings with Health Authorities
Key Responsibilities
Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
• Collaboration with partners to develop and execute global regulatory activities
