Senior Director, Global Regulatory Affairs, CMC at Vertex Pharmaceuticals in Boston, MA

Save or bookmark jobs as you go and access them anytime later with your account.

Contacts

Description

Job Description:

The Senior Director is responsible for overseeing the development and implementation of global regulatory CMC strategies for all large molecule and gene therapy product development. The Senior Director will provide regulatory CMC leadership across projects, teams and committees and will provide strategic and operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions.
Key Responsibilities
  • Lead the GRA CMC large molecule and gene therapy team, reporting to the head of Regulatory CMC
  • Design, develop, and implement regulatory CMC strategy across all large molecule and gene therapy projects
  • Deliver regulatory strategy objectives for GRA CMC, including operational risk management
  • Work collaboratively across functions and teams to develop and implement regulatory CMC strategies
  • Develop and maintain relationships with health authorities and lead the preparation of health authority interactions
  • Develop regulatory strategies integrated with cross-functional project teams to facilitate timely submissions and approvals
  • Provide regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
  • Assess project plans and timelines and assign and manage team effectively to ensure projects are appropriately prioritized and goals are met
  • Evaluate current processes and communication links and assess opportunities for improvement
  • Manage team performance and play a key role in developing career growth opportunities
  • Recognized internally and externally as an expert in large molecule and gene therapy regulations, guidelines and precedents related to pharmaceutical development

#LI-RS1

Qualification:

  • Advanced degree in a scientific discipline
  • 12+ years of pharmaceutical industry experience
  • 8+ years of experience working in regulatory affairs CMC
  • Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
  • Experience in leading CMC submission preparation and Health Authority interactions
  • Strategic thinking and strong problem solving skills
  • Strong interpersonal skills and the ability to communicate effectively cross-functionally
  • Strong oral and written communication skills
  • Sound understanding of CMC and GMP related issues.
  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Proven ability to work with interdisciplinary teams and dealing with unfamiliar situations

Similar Jobs

See All »

Other Jobs at Vertex Pharmaceuticals

See All »