Associate II, Complex Gx, Regulatory Affairs Teva Pharmaceuticals

4.0 - 8.0 years

0 Lacs

bangalore, karnataka

On-site

As an Associate II in Complex Gx, Regulatory Affairs at Teva Pharmaceuticals, you will be responsible for the preparation and submission of high-quality regulatory filings for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. Your role will involve managing regulatory submissions, collaborating with cross-functional teams, evaluating change controls, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. Additionally, you may serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives. Key Responsibilities: - Prepare, review, and compile new submis...

Posted 1 week 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 1 month ago

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Regulatory Affairs Manager Ruchita Hiraji Thakur Mumbai

8.0 - 10.0 years

12 - 20 Lacs

vadodara

Work from Office

Lead the preparation, review, and submission of new regulatory dossiers for Solid Oral Dosage Forms (SODF), Injectables, and/or Ophthalmic products to regulated markets. Lifecycle,Labelling Management, Stakeholder,Team Leadership,Process Improvement

Posted Date not available

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