Associate Director Regulatory Strategy

3 hours ago

Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time
Job Title: Associate Director Regulatory Strategy

Agios Pharmaceuticals is seeking an experienced Associate Director of Regulatory Strategy to join our growing Regulatory team. As a key member of our team, you will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the organization.

Key Responsibilities:
  • Develop and execute global regulatory strategy 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 related scientific discipline; advanced degree preferred.
  • Associate Director: Must have minimum of 8 years pharmaceutical industry with 6 years in Regulatory affairs strategy.
  • Strong demonstration of knowledge of drug development, FDA, EMA, and ICH guidelines and regulations.
  • Excellent organizational and communication skills, both written and verbal.
  • Ability to work independently as well as part of a team environment.
  • Positive attitude, energetic, and proactive.
  • Proven ability to manage multiple projects, identify, and resolve regulatory issues.
  • Strong interpersonal skills and the ability to effectively work with others.
What We Offer:
  • Deliberate Development. Your professional growth as one of our top priorities.
  • Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health, and wellness approaches, care of families, and productivity.
  • Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
  • Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
  • Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly, and take data-informed risks to help push the boundaries.
  • Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.
  • Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

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