Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Johnson & Johnson strives to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life. The organization is comprised of more than 250 operating companies with over 127,000 employees located in some 60 countries. With Global sales of USD 71.3 billion in 2013, Johnson & Johnson is recognized as one of the most admired and respected companies in the world. Johnson & Johnson companies are equal opportunity employers.
Post : Sr. Executive Regulatory Affairs
Responsibilities:
Strategic Regulatory Affairs & Quality Compliance (SRAQC) 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, APAC and IB market, 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, APAC and IB market 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.
- Other assignment identified and assigned by Supervisor/ management- time to time.
Candidate Profile :
* Graduate/ Post Graduate in Lifescience/ Bio Medical/ Pharmacy
* Minimum 1-3 years Industry Experience in Regulatory Affairs, preferably in medical devices.
* 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
Location: Gurgaon, India
Job ID: 1700164275W
End Date: 10th June, 2017
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