Senior Regulatory Affairs Manager Biocon Biologics Limited

15.0 - 22.0 years

25 - 40 Lacs

bengaluru

Work from Office

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • 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 • DMF preparations, review of changes and routine updates to Global Regulatory Agencies • Dossier p...

Posted 5 hours ago

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Technical Assistant - Biosimilar Cadila Pharmaceuticals

2.0 - 5.0 years

2 - 5 Lacs

Dholka

Work from Office

Role & responsibilities • Raw materials and Consumables transfer from Warehouse to Drug substance manufacturing area • Transfer of Raw material from Day store to Drug substance manufacturing area • Transfer of Formulated bulk from Drug substance manufacturing area to Injection manufacturing • Cleaning of Glass ware, Vessel and Utensils • Operation of Dry Heat Sterilizer, Steam sterilizer, Decontamination Autoclave and Particle Counter • Perform Manufacturing activities in strict accordance with standard Operating procedures and cGMP guideline • Arrangement of Equipment/ Instruments and Cleaning of Equipment/ Instrument • Online Documentation for the operations • Assist vendors during annual ...

Posted 2 months ago

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Manager, Regulatory Affairs (Biologicals) Domestic Market Eris Lifesciences Ltd

9.0 - 10.0 years

16 - 18 Lacs

Ahmedabad

Work from Office

Key Responsibilities: 1. Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. 2. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. 3. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. 4. Cross-functional Collaboration: Work closely with R&D, Clinic...

Posted 3 months ago

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