Vacancies for Life science and Pharma candidates for Senior Executive in Regulatory Affairs @ Johnson & Johnson
Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India, under guidance and instructions of Supervisor.
Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India in accordance with applicable regulations and relevant guidelines, under guidance and instructions of Supervisor.
Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise.
Gathers and assembles information/ technical & regulatory documents through various modes (email/ document request tools/ T-cons) in timely manner ensuring regulatory application submissions as per defined plan/ commitment.
Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises.
Maintain the changes to the Regulations/Products/Sites and make necessary submission, as assigned, to maintain compliance to Country Regulations
Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / Admin assistant and work as per the applicable SOPs and guidelines
Maintenance of RA database for the responsible franchises in Trackwise tool (PRIM) & MDRIM.
Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA/ RALI team through email/ trackwise.
Control of regulated/ non-regulated products/ codes in RA gateway tool.
Coordinate with source RA and other stakeholders for tender related regulatory support and responsible for update and maintenance of Tender related sharepoint.
Other assignment identified and assigned by Supervisor/ management- time to time.
Skill and Behavioral
• Sound understanding of MD&D rules and regulations in India.
• Experience of Submitting, Registering and maintaining Product registrations with MOH
• Experience in quality/ manufacturing and regulatory affairs in medical devices would be advantage
• Experience in assembling product dossiers for submission to Regulatory Authorities.
• Good technical writing, communication skills and negotiation skills.
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