Regulatory Affairs Manager Responsibilities and Duties

Participate across Global Regulatory Team to develop product label along with core data sheet working with Labeling Working Group.

Define commercial goals and objectives conforming to expected and available scientific data, precedent and regulatory guidance.

Install and provide on time regional regulatory resources to GDT and various cross-functional project meetings complying with GRT strategy.

Analyze and convey impact of applicable regional guidance, regulations, existing regulatory environment along with competitor labeling.

Guide on local regulatory mechanisms to optimize product development.

Support GDT to prepare study reports, protocols and development plans to achieve regulatory approval along with product labeling supporting key messages.

Develop and maintain documents of product regulatory history through IMR and apt archive of all regulatory documents as well as agency communications.

Guide and provide expertise on teams for cross-functional and interdepartmental teams.

Conduct process enhancement standards development along with metrics.

Supervise, evaluate and recommend GSK business on current and emerging universal regulatory requirements and trends.

Coordinate with other department managers and associates to search critical success factors.

Perform with other organization personnel to develop measurement systems and execute continuous process enhancement methodologies.

Define and manage an end-to-end test atmosphere comprising but not constraint to selection of methods, tools and process.

Ensure timely delivery of new projects.

Comply product performance and quality with company established specifications.