Associate Director of Global Regulatory Strategy

2 days ago

Boston, Massachusetts, United States Lifelancer Full time
About the Job

We are seeking an experienced Associate Director to join our Global Regulatory Affairs team as a Global Regulatory Project Management Lead. This role will provide strategic leadership and guidance on global regulatory project management for moderately complex programs and submissions.

The ideal candidate will have a minimum of 8 years of experience in regulatory project management, preferably with 4 years in Global Regulatory Affairs. Experience working on late-stage filings is highly preferred.

As a key member of our team, you will be responsible for providing regulatory operational support and guidance, managing multiple projects within assigned timelines, and collaborating with cross-functional teams to ensure seamless execution of regulatory milestones.

This is an excellent opportunity to work with a patient-focused company that values innovation and excellence in everything we do. Join us in our mission to deliver Better Health and a Brighter Future to people around the world.

Key Responsibilities:

  • Provide strategic leadership and guidance on global regulatory project management for moderately complex programs and submissions.
  • Manage multiple projects within assigned timelines and collaborate with cross-functional teams to ensure seamless execution of regulatory milestones.
  • Provide regulatory operational support and guidance to program teams.
  • Collaborate with the Global Regulatory Lead (GRL) to ensure global regulatory project plans are established and maintained.
  • Directly supports program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless, and delivering to expectations.
  • Elevate high-impact business-critical issues and potential critical issues together with proposed plan of action to GRL and management.

Requirements:

  • Bachelor's degree required; emphasis in science preferred. Advanced degree preferred.
  • Minimum 8 years of experience in regulatory project management, preferably with 4 years in Global Regulatory Affairs.
  • Experience working on late-stage filings is highly preferred.
  • Advanced education or credentialing in regulatory affairs and project management preferred.
  • Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and process is required.
  • At least two major eCTD (original or supplement) registrations and several minor (amendment) filing experiences in the USA or more jurisdictions.
  • Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support is needed.
  • Proven ability to provide regulatory operational support and guidance.
  • Able to deal with issues of critical importance and provide regulatory operational advice and make reasoned decisions on regulatory operational issues.
  • Demonstrates leadership, problem-solving ability, flexibility, and teamwork.
  • Exercises good judgment in elevating and communicating actual or potential issues to line management.
  • Active participation in Industry groups/forums expected.
  • Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging.
  • Excellent interpersonal and negotiation skills.
  • Demonstrates strong ability to collaboratively lead without line authority, interact, and work effectively with other departments as well as external organizations.
  • Excellent organizational skills, ability to multitask, and with attention to detail; capable of managing multiple projects within assigned timelines.
  • Ability to apply scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
  • Analytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives.
  • Expertise with project management-related software and tools (e.g., MS Project, OnePager, Office Timeline, SharePoint).

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