Regulatory affairs specialist-Delhi

RESPONSIBILITIES:

- Engaging in core Regulatory activities including:

- Liaise with manufacturers to obtain documents for device submissions in India and Sub-continent countries.

- Submit applications for all regulated devices to Drug Controller General of India (DCGI) office.

- Submit applications for all the products using Radio Frequency (RF) to Wireless Planning and Co-ordination (WPC) office.

- Assemble technical documentation for inclusion in regulatory dossiers for submission to DCGI and WPC office.

- Interface with DCGI and WPC officers to resolve Regulatory issues affecting SJM India.

- Coordinate and respond to requests received from DCGI, WPC office and Sub-continent countries Regulatory agency.

- Liaise with SJM and non SJM manufacturers regarding device modifications and timing of future device submissions.

- Ensuring upload of regulatory submissions dossiers (New/ Endorsement/ Renewal/ change note/ Queries/ Query responses) on Asia Sharepoint and India Document Management System (DMS).

- Ensuring registration certificates and Import licenses for approved devices are current and up to date on India sharepoint.

- Achieve timely approval of Medical devices to enable the marketing of these products in India.

- Support company sales targets through timely product approvals aligned with Marketing strategies.

- Support Sales team to provide regulatory documents coordinated with US RA team for tender submissions.

- Maintain Approval tracking documentation for India and Sub-continent countries.

- Develop and maintain RA strategic plans for future key technology products.

- Build strong relationships with manufacturers to facilitate their understanding of South Asia's regulatory requirements.

- Co-ordinate with Supply Chain and US RA team to track approvals nearing expiration in the near future to plan inventory accordingly.

- Create Regulatory Affairs monthly report.

- Support Manager in preparing for Quaterly Business Review Meetings.

- Support Manager in preparing for AOP for Regulatory Affairs Function.

- Convene Regulatory meetings.

- Helping the supply chain in removal of GTS block on products as and when required

- Perform other related functions and responsibilities as directed by Manager.

QUALIFICATIONS :

- Masters in Pharmacy/ Biotechnology/ MBA in Pharmaceutical administration with 4-6 years of Regulatory experience with CDSCO office. Regulatory Experience in Medical Devices preferred.

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