R&D Management - GMDA

Vertex Pharmaceuticals, Inc Boston, MA
Job Description

The Manager is responsible for developing and implementing innovative regulatory strategies in support of various projects and sub-teams. As a Regional Regulatory Lead, the Manager is responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registration and life cycle management in their region and is the main point of contact for Regulatory Authorities for an assigned project.

KEY RESPONSIBILITIES:

* Responsible for specified regulatory deliverables for multiple development programs, working with the Global Regulatory Lead, cross-functional stakeholders and consultant(s), as needed

* Represent GRA on cross-functional teams, such as study execution teams or other sub-teams, as the regulatory subject matter expert

* Develop, drive and coordinate regulatory timelines, working closely with the Global Regulatory Lead and other key stakeholders

* Work with the Global and Regional Labeling Lead to support the development of the regional labeling strategy

* Prepare, review and/or approve regulatory submission documents and regulatory authority communications

* As the Regional Regulatory Lead, serve as the main point of contact with regulatory authorities

* Ensure compliance of regulatory strategies and submissions with current regulations and guidance

* Contribute to the continuous improvement of existing department processes and strategies, providing recommendations in their area of expertise

Minimum Qualifications

* Bachelor's degree in relevant scientific discipline, higher degree desirable

PREFERRED QUALIFICATIONS:

* Ph.D. (or equivalent degree) and 2+ years of relevant work experience, or

* M.S. (or equivalent degree) and 4+ years of relevant work experience, or

* B.S. (or equivalent degree) and 6+ years of relevant work experience

* Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from the US

* Ability to effectively collaborate with internal and cross functional colleagues at all levels of the organization to achieve business objectives

* Strong written and oral communication, listening, and non-verbal communication skills

* Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment

* Capable of strategic thinking and proposing innovative solutions to regulatory problems

* Knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development

* Actively pursues innovation and excellence and is able to motivate others to pursue these values.

#LI-KF1