3.0 - 7.0 years

0 Lacs

guwahati, assam

On-site

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your role involves facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. Your responsibilities include: - Reviewing documents related to Quality Management System (QMS) & Compliance - Ensuring compliance of Quality Management System - Attending Site Training Program as per site training program and Global Quality Standards requirements - Submitting dossier documents after review against requests received from Corporate regulatory affairs - Responding to queries for submitted dossier against requests receiv...

Posted 2 weeks ago

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Manager Sun Pharma Laboratories Ltd

5.0 - 9.0 years

0 Lacs

guwahati, assam

On-site

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your primary responsibilities will include: - Facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. - Reviewing documents related to Quality Management System (QMS) & Compliance. - Ensuring compliance of the Quality Management System. - Participating in Site Training Programs as per site and Global Quality Standards requirements. - Submitting Dossier documents after review against requests received from Corporate regulatory affairs. - Responding to queries related to submitted dossiers as per requests from...

Posted 1 month ago

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Walk In For Regulatory Affairs - US/EU/CA -Executive/Sr Executive Shilpa Medicare

2.0 - 7.0 years

2 - 7 Lacs

Hyderabad

Work from Office

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Posted 3 months ago

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Regulatory Affairs - US/EU/CA -Executive/Sr Executive Shilpa Medicare

2.0 - 7.0 years

2 - 7 Lacs

Hyderabad

Work from Office

Posted 3 months ago

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Sr Associate - Compendial Review, Documentation Par Pharmaceutical

5 - 10 years

5 - 9 Lacs

Navi Mumbai

Work from Office

Job Posting Title Sr Compendial Review Associate Job Description Summary Job Description Summary • Performing identification of Pharmacopeial Updates and its review. Implementation of Pharmacopeial updates Globally through change management process. Performing activity related to revision of product specification and method. To support audit activity as per requirement. Incident & Change control review. CAPA implementation. Review and implementing the common procedures as per department requirement. Review of ISO Guideline update. Job Description: - Identification, review and Implementation of Pharmacopeial updates Globally. Performing activity related to revision of product specification an...

Posted 5 months ago

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