Job title: Sr. Executive, Regulatory Affairs

Overall purpose of job:

• Regulatory and quality compliance for the entire Johnson & Johnson Medical franchises in India

• To maintain the Life cycle management of the product registered by Johnson & Johnson

• Developed regulatory strategies along with internal stakeholders to coordinate and mitigate interdependencies of overlapping projects to successfully submit application to HA averting any business impact

• Ensures compliance with regulatory agency regulations and interpretations

Essential duties and responsibilities:

• 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 market in accordance with applicable regulations and relevant guidelines.

• Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise.

• Update and live maintenance of business plan in sharepoint for assigned 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 Product applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines.

• Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management)

• 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

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

• Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals.

• 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 team through email/ other portal.

• Ensure on time archival of regulatory submission documents.

• 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.

Special requirements:

• Strong knowledge of Medical Device Rule 2017 and Drugs and Cosmetics Act

• Knowledge in the international regulations of Medical Devices in US and EU

• Sound knowledge on Medical Device Quality Management System ISO 13485

• Excellent proficiency with software tools

Job location:

Gurgaon, Haryana- India Essential knowledge and skills:

• Graduate/ Post Graduate in Lifescience/ Bio Medical/ Pharmacy

• Minimum 2-6 years Industry Experience in Regulatory Affairs, preferably in medical devices. Sound understanding of MD 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 and communication skills.

Core competencies required for this role:

• Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook

• Translate insights into innovative and viable products or solutions that create value

• Challenge the status quo; lead and adapt to change

• Engage in transparent and constructive conversations