Executive - Regulatory Affairs, Mumbai

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https : / / www.jnj.com

Job Function :

Regulatory Affairs Group

Job Sub Function :

Regulatory Product Submissions and Registration

Job Category : Professional

All Job Posting Locations :

Mumbai, India

Job Description :

• Daily updating of the trackers, tracking submitted applications for India, updating team on queries, new notifications received & daily dispatches if any.
• Archival for documents like approvals, query letters etc in appropriate manner
• Sharing NMRA updates.
• Support operational activities for product registrations in India for Communicable Diseases, Metabolics, Neurology and Established Products portfolio- Making complete dossiers and query responses within specified timelines
• Coordinate with global team to arrange required FP samples & reference standards required for testing at Governments labs as a part of registration.
• Support operational activities for lifecycle management Communicable Diseases, Metabolics, Neurology and Established Products portfolio- filing of RC & IL renewals in timely manner to ensure business continuity
• Coordination with Regional Regulatory for Supporting documents required for various applications for submission
• Support with operational activities to other team members as and when required
• Support for sample testing at Government labs or equivalent labs as required
• Maintain database for SEC meeting minutes.
• Back up for ARR related QMS documentation

Required Skills : Preferred Skills :

Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Execution Focus, Market Research, Package and Labeling Regulations, Process Oriented, Product Licensing, Product Packaging Design, Project Management, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety-Oriented]]>