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Pharma Regulatory Affairs officer

Pharma Regulatory Affairs officer

Syngene

5 - 10 years

10 - 15 Lacs

Bengaluru

Posted:1 hour ago| Platform:

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Skills Required

Regulatory Affairs Licensing national regulatory affairs Regulatory Compliance

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Work from Office

Job Type

Full Time

Job Description

Core Purpose of the Role: To assist pharma regulatory team of Syngene in executing submissions for various licensing activities and follow up with regulators to ensure timely approvals. Role Accountabilities: a) Preparation and submission of CT-10, CT-12, CT-13, CT-16, Form 12 applications to CDSCO (biological and small molecules), Export NOC, Form 29, GMP, WHO-GMP, license retention, Form 37, COPP, WC and endorsement applications to CDSCO and SLA as applicable. b) Respond to regulators queries by collaborating with internal and external stakeholders. c) Follow-ups for approvals with CDSCO, Zone, SLA and NCB. d) Filling quarterly returns to NCB and maintain compliance to RCS, 2013. e) Supporting the team in preparation of IBSC and RCGM application, coordinate and convene IBSC meetings on behalf of member secretary, IBSC. f) Providing consultation to the internal stakeholders and clients regarding national regulatory requirements as and when required. g) Maintenance of all submissions and approvals record by maintaining database and trackers. Manufacturing licenses (R&D and commercial), import and export permissions, liaising with State regulators. h) Providing time to time update to the stakeholders on the licenses and participating in teleconferences/ discussions with stakeholders / clients as required. i) Prepare new SOPs as and when required, update current SOPs periodically. j) Keep all operating units updated on recent change in rules and regulations governing product development life cycle.

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Syngene

www.syngeneintl.com

Research Services

Bengaluru Karnataka

5001-10000 Employees

103 Jobs

Key People

Dr. Peter G. H. Wilding

Managing Director
Ravi Kumar

Chief Financial Officer
Anand Kumar

Chief Operating Officer
Sanjay S. B. Ghosh

Senior Vice President of Research

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