Johnson & Johnson Career Opportunity Regulatory Affairs Executive (Gurgaon)

Johnson & Johnson (J&J), a global leader in healthcare innovation, is recruiting a Regulatory Affairs Executive to join its team. This role is crucial for ensuring regulatory and quality compliance across J&J Medical franchises in India, contributing to the company’s mission of profoundly impacting health for humanity.

Application Details

Post: Regulatory Affairs Executive
Function: Regulatory Affairs Group
Location: Gurgaon / India
Industry Type: Pharma / Healthcare / Clinical Research
Application End Date: 30th November 2025

(Note: The news post does not contain a direct application link. Interested candidates should apply online via the Johnson & Johnson careers portal before the deadline.)

Candidate Profile and Qualifications

Requirement	Details
Education	Graduate or preferably Postgraduate in Sciences/Life Sciences/Pharmacy/Biomedical/Engineering.
Required Knowledge	Basic understanding of Medical Devices Rules, 2017 (India) and CE Marking of Medical Devices.
Skills	Good Oral & Written Communication, efficiency in drafting letters and preparing responses to the India Health Authority (HA). Proficient in MS-Word, Excel, and PowerPoint.

Key Responsibilities

The Regulatory Affairs Executive will manage the product registration lifecycle and ensure continuous compliance:

Regulatory Submissions: Draft, review, submit, and archive regulatory filings for the India market, including New Registrations, Re-registrations, and Legal-Physical Manufacturer Transfers.
Post-Registration Management: Handle and archive submissions related to post-registration regulatory lifecycle management, such as Query responses, Corrections fillings, and miscellaneous notifications.
Internal Documentation: Create and maintain the Product Registrations Request Form (PRRF) for registration activities and Change Controls for product discontinuations/changes.
System Maintenance: Update and maintain the business plan in online systems and the RA database for assigned franchises/licenses.
Stakeholder Coordination: Coordinate with internal stakeholders (via email/phone/document request tools) to ensure the time-bound availability of documents required for regulatory applications.
Compliance & Training: Ensure compliance with regulatory agency regulations. Complete mandatory online trainings and work strictly as per applicable SOPs and guidelines.
Strategic Support: Develop regulatory strategies in coordination with internal teams to mitigate interdependencies of overlapping projects and successfully submit applications to the Health Authority, avoiding business impact.