Associate Director, Regulatory Publishing

Vertex Pharmaceuticals Incorporated

Hybrid
Extensive regulatory publishing experience
Expertise in electronic document management systems
Knowledge of health authority electronic submission guidance
Vertex Pharmaceuticals is seeking an Associate Director of Regulatory Publishing to lead complex submission activities and manage the lifecycle of regulatory documents. The role requires extensive experience in publishing software and regulatory operations, as well as strong organizational and communication skills

Job Summary

  • The role is accountable for leading complex publishing activities across a portfolio of inter-related submissions while ensuring accuracy against health authority requirements.
  • Candidates must possess extensive experience in regulatory operations, including managing vendor relationships and validating electronic document management systems.
  • This position offers flexible work arrangements allowing employees to choose between remote, hybrid, or on-site schedules subject to company policy.

Matching Summary

Match Score: 85

Vertex Pharmaceuticals is seeking an Associate Director of Regulatory Publishing to lead complex submission activities and manage the lifecycle of regulatory documents. The role requires extensive experience in publishing software and regulatory operations, as well as strong organizational and communication skills.

Skills & Requirements

Must-have

  • Extensive regulatory publishing experience
  • Expertise in Electronic Document Management Systems
  • Knowledge of health authority electronic submission guidance
  • Vendor management and outsourcing oversight
  • Proficiency in industry standard publishing software

Nice-to-have

  • Ability to train and educate team members
  • Strong cross-functional stakeholder influence
  • Experience with GIS technical collaboration
  • Adaptability to changing priorities and deadlines

Key Requirements

  • Bachelor's Degree in life sciences or equivalent experience
  • Extensive Regulatory Operations/Publishing experience
  • Specialized knowledge of ICH regulations and controlled documents

Work Rights

Not specified

Tailored Resume

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