Associate Director Regulatory Strategy
3 days ago
Agios Pharmaceuticals is seeking an Associate Director of Regulatory Strategy to join our growing Regulatory team. This role 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 strategies for long-term planning, including expedited development needs.
- Provide global regulatory expertise in support of development, review, and approval of strategies and documents for clinical trials and marketing authorizations.
- Plan, lead, develop, and review regulatory submissions, including clinical trial and marketing applications, life-cycle management submissions.
- 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.
- Bachelor's degree in life sciences or a related scientific discipline; advanced degree preferred.
- Minimum of 8 years of pharmaceutical industry experience with 6 years in Regulatory Affairs strategy.
- Strong 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.
- 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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