Assistant Manager- Regulatory Affairs

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 Affairs

Job Category

Professional

All Job Posting Locations:

Gurgaon, Haryana, India

Job Description

Helps establish and implement compliance with regulatory agency regulations by providing advanced knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements. Analyzes and interprets scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market. Confers on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets. Coaches product development teams on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process. Assists in managing, preparing, and submitting detailed regulatory submissions required for new and existing product approvals and registrations. Establishes Regulatory Affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports to support internal and external audits. Coaches more junior colleagues in techniques, processes and responsibilities. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.