Regulatory Affairs Strategist

4 hours ago


Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

At Agios Pharmaceuticals, we're seeking a skilled Regulatory Affairs Strategist to join our growing Regulatory team.

This individual will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the organization.

The successful candidate will prepare and oversee the development of compliant, high-quality, nonclinical and clinical global regulatory submissions to support early development, registration, and life cycle management.

Key Responsibilities:

  • Develop and execute global regulatory strategies for long-term planning, including the potential to accommodate expedited development needs.
  • Work within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations.
  • Plan, lead, develop, and review regulatory submissions, such as clinical trial and marketing applications, life-cycle management submissions.
  • Plan and lead health authority interactions and develop or contribute to the development and review of associated documents.
  • Manage and mentor individuals within the regulatory affairs team, providing guidance and support as needed.
  • Engage with Regulatory Authorities on project-related matters, as needed.
  • Ensure adherence to current regulations associated with regulatory activities.

Requirements:

  • Bachelor's degree in life sciences or a related scientific discipline.
  • Minimum of 8 years of pharmaceutical industry experience with 6 years in Regulatory Affairs strategy.
  • Positive attitude, energetic, and proactive.
  • Proven ability to manage multiple projects, identify, and resolve regulatory issues.

What We Offer:

  • Competitive performance-based compensation.
  • Flexible work arrangements, including remote work options.
  • A comprehensive benefits package that includes health, wellbeing, and security benefits.


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