Regulatory Affairs Specialist Biocon Biologics

0.0 years

0 Lacs

bengaluru, karnataka, india

On-site

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 preparation...

Posted 3 weeks ago

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QA RA Manager Lywo Hyderabad

15.0 - 20.0 years

10 - 14 Lacs

dombivli

Work from Office

We are seeking a detail-oriented Deputy Manager Quality Assurance to support robust QA operations and also some Regulatory Affairs functions at Acharya Group's API manufacturing unit. This role focuses on maintaining our Quality Management System (QMS) for API production, ensuring cGMP and regulatory compliance for EU, USFDA, PMDA, and other Major Regulatory Regions. Key responsibilities include participating in batch release and continuous improvement; overseeing validation of API manufacturing processes, equipment, and analytical methods, managing deviations, conducting investigations, and implementing CAPA plans. Candidates must have prior experience in Quality Assurance within API manufa...

Posted 1 month ago

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QC - Chemist / Executive GLOBAL CALCIUM

1.0 - 5.0 years

0 Lacs

hosur, tamil nadu

On-site

You are invited to join Global Calcium Pvt. Ltd., a prominent API manufacturing company located in Bangalore, India, specializing in speciality API's, benzodiazepines, ophthalmics, oncology, chelated minerals, and organic mineral salts. We are currently seeking talented individuals to fill various roles in the QC Department. Open Positions: - QC ICP-MS Analyst (2 openings) - QC DMF Support (2 openings) - QC Analytical Validation Support (2 openings) - QC Wet Analysis (2 openings) Qualifications: - B.Sc./M.Sc. in Chemistry or related fields - 1 to 4 years of relevant pharmaceutical QC experience - Familiarity with cGMP practices and regulatory compliance Responsibilities: - Perform routine an...

Posted 1 month ago

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