Summary

Coordinates and prepares submissions to regulatory authorities worldwide. Compiles all materials required for submissions. Reviews and approves clinical trial submissions prepared by external sources. Keeps abreast of regulatory procedures and practices. Develops and documents department best practices.

Duties and Responsibilities

·         Liaise proactively with other functions and participate as departmental member of cross functional teams, representing department position and ensuring teams accomplish requirements on time.

·         Lead and coordinate the preparation (including authoring when relevant), review, and submit regulatory documents that are complete and in compliance with applicable regulations throughout the lifecycle of a product.

·         Assist with development of effective regulatory strategies for global product development.

·         Interact with external regulatory personnel (e.g., FDA, HC, EMEA) as appropriate.

·         Interact with external regulatory personnel at contract research organizations to develop submission plans and to coordinate preparation and submission of documents.

·         Review documents from other departments. Provide advice as to regulatory acceptability.

·         Interact with representatives of partner companies to ensure regulatory acceptability of project outputs and program success.

·         Prepare interpretive analyses of regulatory documents including guidances and regulations that impact ARIAD’s products and operations.

·         Keep abreast of ever changing regulatory environment to ensure best practices are implemented at ARIAD.

Minimum Requirements

Bachelor’s degree in a science-related field. Five-8 years pharmaceutical regulatory experience, preferably with oncology products. Expert project management and interpersonal skills. Excellent written and verbal skills, and team-based working experience. Strong problem solving ability.