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Description

Associate Director, Regulatory Project Manager

Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicine and multiple first-in-class investigational therapies in clinical or preclinical development.

Agios Pharmaceuticals is searching for a dynamic Associate Director, Regulatory Project Manager to join our growing Regulatory Operations team. This newly created role will be responsible for project management activities including planning, coordination, and execution of high quality regulatory submissions of original applications (i.e. NDAs, MAAs, INDs) and any subsequent major amendments, supplements and variations for assigned programs. The person in the role will have the opportunity to establish and implement processes around the way in which we plan for Global Health Authority submissions.

Key Responsibilities

• Responsible for partnering across Regulatory (Strategic Regulatory, CMC Regulatory, Ad-Promo Regulatory and RegOps) and with cross functional project teams to ensure regulatory timelines and strategies are developed and seamlessly executed upon, enabling successful filings with Global Health Authorities.
• Facilitates and co-leads product/submission-specific multi-disciplinary, cross-functional teams, working with all major contributors, including, but not limited to: Regulatory, Medical Writing, Preclinical, Biostatistics, etc. to set expectations and ensure timelines are met.
• Develop and actively manages and monitors project timelines and integrated submission project plans to ensure timelines remain on schedule.
• Work with each function in detail to understand the individual deliverables and interdependencies between deliverables, in order to create and maintain an overall project plan timeline across all Modules (Modules 1-5).
• Identify and communicate both regulatory and project risks, with potential solutions to cross-functional project team and leadership as needed.
• Prepare meeting agendas, meeting minutes and document decisions, action items and effective issue and risk mitigation plans. Organize and maintain this team information in a central location.
• Prepare and distribute reports and trackers to communicate updates and project status.
• Proactively drive project/submission teams and establish an appropriate level of urgency with a keen focus on deliverables.
• Manage the review cycles and any follow up round tables as needed per the filing timelines.
• May plan, manage preparation for, and attend Regulatory Health Authority interactions and assist in preparing meeting minutes.
• Conduct lessons learned sessions to identify areas for improvement.
• Provide senior oversight, influence and guidance to other submission managers.
• Standardize process to view/manage overall, cross-portfolio Regulatory submission workload and view dashboard of submission status.
• Tracks overview of all major submission and health authority activity to aid in Regulatory resource planning.
• Maintains up to date knowledge of health authority regulations and guidance documents as well as ICH guidelines.

Requirements

• Bachelor

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