Senior Manager, RA Labeling Product Leader

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:
PL002 Iłżecka

Job Description:
Facilitates compliance with regulatory agency regulations by providing expert counsel to enable products that are developed, manufactured, or distributed to meet required legislation.

Conducts advanced analysis and interpretation of scientific data in assessing risk and in the creation of regulatory strategies to expedite new product introductions to the market.

Consults on critical 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.

Applies advanced knowledge of Regulatory Affairs on product development teams for input on product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.

Directs teams in managing, preparing, and submitting detailed regulatory submissions required for new and existing product approvals and registrations.

Provides 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.

Guides junior colleagues through consultation and mentoring in techniques and processes, and provides functional (matrix) supervision.

Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.