Senior Regulatory Affairs Specialist

J&J Family of Companies Senior Regulatory Affairs Specialist in Petaling Jaya, Malaysia

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

Job Description:

1. Implements compliance with regulatory agency regulations by providing knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements.
2. Completes thorough analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.
3. Applies in-depth knowledge 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.
4. Identifies opportunities 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.
5. Completes detailed regulatory submissions required for new and existing product approvals and registrations.
6. Communicates 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.
7. Coaches more junior colleagues in techniques, processes and responsibilities.
8. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine