Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products. The organization comprises of more than 250 operating companies with over 130,000 employees, located in over 60 countries. Johnson & Johnson is recognized as one of the most admired and respected companies in the world. In India, Johnson & Johnson operates as a single legal entity and consists of 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
Job Description
- 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.
- Assist in the preparation of technical presentations/ meetings with regulator.
- 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 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).
- 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.
Candidate Profile
- Graduate/ Post Graduate in Lifescience/ Bio Medical/ Pharmacy
- Minimum 1-3 years Industry Experience in Regulatory Affairs, preferably in medical devices & biologicals.
- Sound understanding of MD&D rules and regulations
- 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.
Additional Information:
Experience: 1-3 years
Qualification: M.Pharm, M.Sc, B.Pharm
Location: Haryana-Gurgaon
Functional Area: Regulatory Affairs
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th July, 2017
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