Regulatory Affairs Sr Executive/ Manager

2 weeks ago

New Delhi Okhla Phase, India Pharmeda Healthcare Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Must Have Knowledge of CTD & Country Specific Dossiers Compilation, Site Master Files (SMF) & Stability Study Reports Regulatory Submissions:

Prepare and submit regulatory documentation, including applications, amendments, and notifications to health authorities.

Ensure compliance with regulatory requirements for product registration, labeling, and advertising.

Regulatory Compliance:

Monitor and track regulatory changes and updates to ensure compliance.

Conduct regulatory impact assessments and provide guidance to cross-functional teams.

Documentation Management:

Maintain accurate and up-to-date regulatory records and documentation.

Organize and manage regulatory files for easy access and retrieval.

Regulatory Affairs Projects:

Support regulatory projects, such as product launches, lifecycle management, and post-market surveillance.

Coordinate with cross-functional teams to ensure timely completion of regulatory tasks.

Regulatory Intelligence:

Conduct regulatory research and analysis to identify potential risks and opportunities.

Stay informed about industry trends and regulatory developments.

CTD & Country Specific Dossiers Compilation

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  • Senior Manager Regulatory Affairs

    4 hours ago

    New Delhi, India Panacea Biotec Full time

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    4 hours ago

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    6 days ago

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    5 days ago

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  • Senior manager regulatory affairs

    3 weeks ago

    New Delhi, India Panacea Biotec Full time

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  • Senior Manager Regulatory Affairs

    3 weeks ago

    New Delhi, India Panacea Biotec Full time

    Position: Sr. Manager / AGM – Regulatory AffairsQualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...

  • Senior Manager Regulatory Affairs

    3 weeks ago

    New Delhi, India Panacea Biotec Full time

    Position: Sr. Manager / AGM – Regulatory AffairsQualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...

  • Senior Manager Regulatory Affairs

    3 weeks ago

    New Delhi, India Panacea Biotec Full time

    Position: Sr. Manager / AGM – Regulatory AffairsQualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...