The main task of a Regulatory Affairs Specialist in Johnson & Johnson is to Develops skill set to enable value added individual contributions, who works under close supervision. Applies methods for planning, directing, coordinating and controlling regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Interprets new and changing government regulations to ensure compliance with regulatory/ government standards.

Duties & Responsibilities

Assists by providing knowledge in implementing compliance with regulations to enable products that are developed, manufactured, or distributed meet regulatory agency requirements.

Applies functional analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.

Contributes 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.

Advises 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.

Carries out the detailed regulatory submissions required for new and existing product approvals and registrations.

Coordinates 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.

Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.