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Regulatory Affairs Manager

Regulatory Affairs Manager

Right Advisors Private LimitedMumbai, Maharashtra, India
2 days ago
Job description

Experience- 10-12 Years

Location- Mumbai

Mandatory Skills- Regulatory Affairs, CDSCO,DCGI, SUGAM Portal

Only those candidates can apply whose salary is not more than 24 LPA

Looking from Only Pharma Companies

Key Accountabilities :

Propose efficient regulatory pathway for New Product Introduction

  • Develop & implement regulatory strategies for new / generic product registrations in

compliance with relevant regulations and the business needs

  • Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc.

    • related to new products filing

  • Collaborate with other functions such as R&D, Quality, Supply chain, Project

    • Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with

    business priorities

  • Responsible for end-to-end filing of New products(Drugs / Biologics / Biosimilars etc) to

    • CDSCO (Central Drugs Standard Control Organization), State FDA etc.

  • Well versed with filing application of ND / SND / FDC / Import Registration / Import licence

    • etc on SUGAM portal

  • Address queries from CDSCO / SFDA on submitted applications, provide regulatory

    • support for IPC / CDTL / CDL testing

  • Manage submission of application dossiers with relevant regulatory authorities, monitor

    • the review process and take appropriate actions to obtain regulatory approvals as planned.

  • Responsible for Subject expert committee (SEC) meetings including preparation of slide

    • deck in co-ordination with cross functional teams and SEC deliberation

    Track all SEC meetings to identify and recommend new product ideas / opportunities

    aligned with current business needs

  • Provide Regulatory Support for timely new product launches

    • Minimum Education : M. Pharm / B. Pharm

    Interested candidates please share their resume on sudha.kumari@rightadvisors.com.

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