Assistant General Manager - DQA & RA Hikal

5.0 - 9.0 years

0 Lacs

pune, maharashtra

On-site

As an API Regulatory Affairs Manager, your role involves ensuring that API regulatory activities are carried out according to the specified time schedule and ensuring timely readiness of API regulatory documents/DMFs for new submissions/updates. You will be required to provide necessary regulatory support, advice, and guidance to the concerned API manufacturing sites and R&T Unit. Additionally, you will need to assure the quality of DMF submissions and maintenance, taking into consideration the company's Intermediates business. Your responsibilities also include providing technical inputs to Section Heads for APIs and Key for regulatory adequacy. Key Responsibilities: - Co-ordinate and colla...

Posted 2 days ago

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Head of Research And Development Krishang Pharma Private Limited

15.0 - 20.0 years

0 Lacs

anand, gujarat

On-site

As the Head of R&D at Krishang Pharma Private Limited, you will play a crucial role in driving cutting-edge development for regulated markets. You will be responsible for leading end-to-end product development, scale-up, and technology transfer activities. Collaboration with cross-functional teams will be essential to ensure successful product launches, cost-effective processes, and regulatory readiness. Key Responsibilities: - Lead R&D strategy and execution for corticosteroids, hormones, and general APIs - Oversee route scouting, process development, optimization, and plant scale-up - Ensure adherence to GMP, ICH, and international regulatory standards - Coordinate with QA/QC, Regulatory A...

Posted 1 month ago

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Regulatory Affairs Officer Infinium Pharmachem Limited

1.0 - 5.0 years

0 Lacs

gujarat

On-site

As a Regulatory Affairs Officer at Infinium Pharmachem Limited, located in Sojitra, Anand, Gujarat, you will be responsible for preparing and submitting Drug Master Files (DMFs) for the USA and EU. Your role will involve ensuring compliance with regulatory guidelines and filing procedures, as well as maintaining and updating regulatory documentation for accreditation processes. You will be expected to coordinate with internal teams to gather required data for submissions and liaise with regulatory agencies to address queries and ensure timely approvals. Additionally, monitoring changes in global regulatory requirements and updating documentation accordingly will be a key part of your respons...

Posted 2 months ago

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