Regulatory Affairs Manager (EU/US) Silmed Scientific

4.0 - 8.0 years

0 Lacs

kochi, kerala

On-site

Role Overview: As a Regulatory Affairs Manager, you will be responsible for monitoring the company's production activities to ensure compliance with applicable regulations and standard operating procedures. Your key responsibilities will include devising regulation compliance strategies, creating training programs for staff, conducting internal inspections, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in line with regulatory guidelines, evaluate changes in CMC documentati...

Posted 3 weeks ago

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Regulatory Affairs Manager Silmed Scientific

4.0 - 8.0 years

0 Lacs

kochi, kerala

On-site

Role Overview: As a Regulatory Affairs Manager, your main responsibility will involve monitoring the company's production activities to ensure compliance with relevant regulations and standard operating procedures. You will be tasked with devising strategies for regulation compliance, organizing training programs to educate staff on policies and standards, conducting internal inspections and awareness campaigns, and staying updated on the latest rules and regulations in the industry. Key Responsibilities: - Demonstrate expertise in CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in adherence to ...

Posted 4 weeks ago

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Regulatory Affairs Executive Enzene

3.0 - 7.0 years

5 - 9 Lacs

pune

Work from Office

Position Summary: The Executive Regulatory Affairs (Biosimilars) will be responsible for the preparation, review, and submission of high-quality CMC documentation to support regulatory filings in the US, Europe, and other global markets. The role involves cross-functional collaboration, drafting of eCTD modules, and ensuring compliance with international regulatory requirements for biosimilar products. Role & responsibilities Review and finalize CMC (Chemistry, Manufacturing, and Controls) documents for US (FDA) and European (EMA) regulatory submissions. Draft, compile, and review eCTD sections , ensuring compliance with current regulatory and technical standards. Author and review key regul...

Posted 2 months ago

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Regulatory Affairs, Biosimilars Intas

4.0 - 8.0 years

0 - 0 Lacs

ahmedabad

Work from Office

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

Posted 2 months ago

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Regulatory Affairs Manager (EU/US) Silmed Scientific

4.0 - 8.0 years

0 Lacs

kochi, kerala

On-site

As a Regulatory Affairs Manager, you will play a crucial role in monitoring the company's production activities to ensure compliance with all applicable regulations and standard operating procedures. Your responsibilities will include devising regulation compliance strategies, creating training and orientation programs for staff, conducting internal inspections and information drives, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of Chemistry, Manufacturing, and Controls (CMC) aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents ac...

Posted 3 months ago

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