Regulatory Affairs Strategist
4 hours ago
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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