J&J Pharmacy Executive Job Opening – Apply Online
Job Title: Executive, Regulatory Affairs
Function: Regulatory Affairs Group
Sub Function: Regulatory Affairs
Category: Senior Assistant, Regulatory Affairs (S3)
Location: Gurgaon, Haryana, India
Date Posted: May 06, 2024
Requisition Number: 2406182672W
Description
Job title: Executive, Regulatory Affairs
Overall purpose of the job:
- Regulatory compliance for the medical devices marketed by Johnson & Johnson MedTech India.
- To maintain the lifecycle management of the products registered by Johnson & Johnson.
- Coordinate with internal stakeholders to develop regulatory strategies and mitigate interdependencies of overlapping projects to successfully submit applications.
Essential duties and responsibilities:
- Draft, review, and submit regulatory filings (re-registrations, new registrations, legal-physical manufacturer transfers) for the India market.
- Draft, review, and submit other regulatory submissions (query responses, correction filings, miscellaneous notifications regarding post-registration regulatory lifecycle management) for the India market in accordance with applicable regulations and relevant guidelines.
- Draft cover letters for regulatory communications/submissions depending on the level of regulatory knowledge/expertise.
- Update and maintain the business plan in SharePoint for assigned franchises/licenses.
- Assist in the preparation of technical presentations/meetings with regulators.
- Gather and assemble information, prepare 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 submissions to maintain compliance with country regulations (lifecycle management).
- Coordinate with internal stakeholders to ensure compliant lifecycle management of responsible products/franchises.
- Maintain changes to the regulations/products/sites and make necessary submissions to maintain compliance with country regulations.
- Maintenance of RA database for the responsible franchises in MDRIM tool.
- Ensure timely completion of received change assessment within the due timeline and provide feedback to source RA team through email/other portals.
- 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.
- Ensure on-time archival of regulatory submission documents.
- Understand complaint and adverse event reporting responsibility and report such events within 24 hours of becoming aware.
- Other assignments identified and assigned by supervisor/management as needed.
Special requirements:
- Knowledge of Medical Device Rule 2017 and Drugs and Cosmetics Act.
- Knowledge of international regulations of medical devices in the US and EU.
- Excellent proficiency with software tools.
Job Location: Gurgaon, Haryana, India
Qualifications
Essential knowledge and skills:
- Graduate or post-graduate degree in life sciences, biomedical, or pharmacy.
- Minimum of 2-4 years of industry experience in regulatory affairs, preferably in medical devices. Sound understanding of medical device rules and regulations in India.
- Experience in submitting, registering, and maintaining product registrations with the Ministry of Health.
- 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.
Keywords: Executive, Regulatory Affairs, Johnson & Johnson MedTech India, Regulatory compliance, Medical Devices, Gurgaon, Haryana, India. J&J Pharmacy Executive Job Opening – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
