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

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 Alpha-1 Antitrypsin Deficiency 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 small molecule 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