Associate Director/Director, Global Regulatory Affairs - Strategy (DMD - Boston, Massachusetts, United States, 02298

Job Description

Vertex Pharmaceuticals Inc. is looking to hire an Associate Director/Director to join the Global Regulatory Affairs Strategy team in Boston, MA. The Associate Director/Director will be responsible for overseeing the development and implementation of innovative global regulatory strategies for product development and commercialization of the Duchenne Muscular Dystrophy program and for other early development programs in emerging disease areas. He/she will play a major role in shaping cohesive regulatory strategy across the programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy.

Key Responsibilities:

* Lead the development of regulatory strategy for multiple and/or complex nucleic acid therapy projects in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents
* Represent GRA on Project Teams and collaborate with Regional teams to ensure unified regulatory input into clinical programs and commercial strategy
* Address complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams and GRA leadership
* Anticipate global regulatory changes and develops proactive strategy accordingly
* Review and approve regulatory submission documents and Health Authority communications
* Counsel and advise senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices
* Ensure the global regulatory strategy for a given project is consistent with the business objectives and has been negotiated with relevant health authorities as appropriate
* Ensure compliance of regulatory strategies and submissions with current regulations and guidance
* Assess project plans and timelines and assign and manage resources effectively to ensure all projects are appropriately prioritized and key goals are met on time
* Work to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations
* Contribute to the continuous improvement of existing department processes and strategies, providing recommendations in their area of expertise
* Provide overall regulatory functional leadership to the GRA sub-team in context of participating in the skill development, coaching, and performance feedback for members of the GRA sub- team, regardless of formal reporting relationship

Minimum Qualifications

* Ph.D. and 10+ years of work experience in pharmaceutical regulatory affairs, or
* B.S/M.S. and 12+ years of work experience in pharmaceutical regulatory affairs

Preferred Qualifications

* Capable of strategic thinking and proposing innovative solutions to regulatory problems
* Demonstrates excellent communication skills with ability to impact and influence the decisions of a team
* Communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents
* Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment
* Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
* Ability to communicate with all levels within the company and act as liaison / representative both internally and externally
* Actively pursues innovation and excellence and is able to motivate others to pursue these values