Opportunity for M.Pharm, M.Sc as Regulatory Affairs Manager at Johnson & Johnson

 

Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds.  Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.

Post : Manager - Regulatory Affairs

Job Description
• Ensure complete regulatory deliverables from initial product registration to EOL for assigned Franchises/ Products.
• Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India market.
• 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.
• Lifecycle management- Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations.
• Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise.
• Update and live maintenance of business plan in sharepoint & MDRIM for responsible franchises/ licenses.
• Assist in the preparation of technical presentations/ meetings with regulator.
• Ensures compliance with regulatory agency regulations and interpretations.
• Gathers and assembles information, prepares documents for New Products.
• Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines
• Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises.
• Maintain the changes to the Regulations/Products/Sites and make necessary submission 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 MDRIM.
• Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA/ RALI team through email/ MDRIM.
• Ensure awareness and implementation of Quality Management System Procedures applicable to Regulatory Affairs.
• Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system.
• 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.
• Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA/ RALI team through email/ MDRIM.
• Control of regulated/ non-regulated products/ codes in RA gateway tool.
• Support with on-time inputs for monthly regulatory report for responsible franchises/ products.
• Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner.
• Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware.
• Other assignment identified and assigned by Supervisor/ management- time to time.

Candidate Profile
• Post Graduate in Lifescience/ Bio Medical/ Pharmacy
• Minimum 7-11 years Industry Experience in Regulatory Affairs, preferably in medical devices
• Sound understanding of MD&D rules and regulations in India and knowledge of international Medical Device Regulations.
• Experience of Submitting, Registering and maintaining Product registrations with MOH. Sound knowledge MOH set up, drugs act and registration Procedure.
• Experience in research/D&D, manufacturing and regulatory affairs in medical devices would be advantage
• Understanding of product development, protocols, research reports, and dossier preparation.
• Experience in quality/ manufacturing  and regulatory affairs in medical devices would be advantage
• Experience in assembling product dossiers for submission to Regulatory Authorities.
• Good understanding of ISO/GHTF regulations
• Good technical writing and communication skills. Good technical writing, communication skills and negotiation skills.

Additional Information
Experience : 5+ years
Qualification :
M.Sc, M.Pharm
Location : Haryana-Gurgaon
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Key Account Management
End Date : 20th February, 2019

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