Regulatory Affairs Associate

Key responsibilities:

• Draft, review, submission and archival of Regulatory filings (Re-registrations/ New Registrations/ Legal- Physical manufacturer transfer) for India market under guidance and instructions of RA Leads/ Supervisor.

• Draft, review, submission and archival of Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India market in accordance with applicable regulations and relevant guidelines and instructions of RA leads/ Supervisor.

• Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure.

• Update and live maintenance of business plan in online systems for assigned franchises/ licenses.

• Coordination with internal stakeholders through various modes (email/ phone/ document request tools) to ensure time bound availability of documents for regulatory application compilation and submissions.

• Attend applicable training sessions as well as complete mandatory on-line trainings and summit training records to the supervisor/ Admin assistant and work as per the applicable SOPs and guidelines.

• Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises.

• Maintenance of RA database for the responsible franchises in Internal tool.

• Other assignment identified and assigned by management- time to time. Required Qualification and Core Competencies for the role:

• Graduate or preferably Postgraduate in Sciences/ Life Sciences/ Pharmacy/ Biomedical/ Engineering

• Basic understanding of Medical Devices Rules, 2017 (India) and CE Marking of Medical Devices

• Good Oral & written communication. Efficient in creating draft letters and preparing response to India HA.

• Good hands-on experience in MS-Word, Excel and Power Point Presentation.

Job location: Gurugram, India