About JJMI In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments. J&J; Medical India (JJMI) is the market leader in the Medical Devices Industry in India. It is in the business of caring and providing solutions to doctors, patients, and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Orthopedics, Infection Prevention, Wound Management, Women’s health, Minimally invasive surgery, Circulatory disease management, Blood glucose monitoring and insulin delivery. Illustrative Responsibilities Regulatory Affairs (RA) department is responsible for regulatory and quality compliance for the entire Johnson & Johnson Medical franchise in India and IB Countries (SriLanka, Bangladesh, Maldives, Nepal & Bhutan). 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 applicableregulations 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 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 tool. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA/ RALI team through email/ TrackWise. 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/ TrackWise. Supporting Pharmacovigilance and artwork activities for Biological products Control of regulated/ non-regulated products/ codes in RA gateway tool. Support with on-time inputs for monthly regulatory report. 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. Quality, Regulatory & Compliance (QRC) Responsibilities Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware – Applicable for JDs across all functions Attend applicable training sessions as well as complete mandatory on-line trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines Follow Bio-Safety practices while handling complaint samples and while working in the field – Report any evidence of product tampering, diversion and counterfeiting to the Brand Integrity function -Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner. Qualifications Competency Requirements Graduate/ Postgraduate in Life science/ Bio Medical/ Pharmacy Minimum 4-7 years Industry Experience in Regulatory Affairs, preferably in medical devices. Sound understanding of MD&D; rules and D&C; Act / 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. Leadership Imperatives CONNECT – Inclusively to address health needs. Builds internal and external relationships based on respect Seeks, listens to and incorporates diverse points of view Collaborates openly across boundaries and acts as a team player SHAPE – The future of health through innovation. Inspires and contributes ideas that challenge thinking Courageously tries new things, tests and learns from mistakes Demonstrates resilience and agility to drive and adapt to change GROW- Self and others to become our best Develops self and others to reach their goals Engages in open and honest conversations Drives performance by managing energy and taking ownership for outcomes Primary Location India-Haryana-Gurgaon- Organization Johnson & Johnson Private Limited (8080) Job Function Regulatory Affairs Requisition ID 2105942041W
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