Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.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.
Post : Sr. Executive RA
Role Overview
Executive, Coordinates, Compiles, and submits New Medical Device Registration Applications, Renewal of Medical Device Registration Applications and Product/Site Change Registration Application to the regulatory agencies for India, Srilanka, Bangladesh & APAC market (as applicable), under guidance of Supervisor/ experts.
Responsibilities
- Compilation and submissions of Regulatory filings for India, APAC and adjoining market (Srilanka, Bangladesh, Maldives), under guidance of supervisor
- 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
- Coordination with internal stakeholders to ensure time bound availability of documents for regulatory application compilation and submissions.
- 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 / franchise secretary and work as per the applicable SOPs and guidelines
- Maintenance of RA database for the responsible franchises in Trackwise tool (PRIM).
- Control of regulated/ non-regulated products/ codes in RA gateway tool.
- Other assignment identified and assigned by management- time to time.
Candidate Profile :
- Post Graduate- Lifescience/ Bio Medical/ Pharmacy
- Minimum 1-3 years Industry Experience in Regulatory Affairs, preferably in medical devices.
- 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 skills.
Additional Information:
Qualification: M.Pharm/M.Sc
Location: Haryana-Gurgaon
Job Function: Regulatory Affairs
Requisition ID: 1600113215W
See All Ph.D Alerts M.Pharm Alerts M.Sc Alerts Kolkata Alerts
See All Other Jobs in our Database
.png)
