Director/ Senior Director, Regulatory Strategy (Pediatrics)

The Impact You Will Make

Agios Pharmaceuticals is searching for a dynamic Director/Sr Director, Regulatory Strategy to join our growing Regulatory Strategy team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Director/Sr Director, Regulatory Strategy will be responsible for developing regulatory strategies to support pediatric clinical development plans, working cross-functionally across the organization. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.

What You Will Do

• Develop and execute global regulatory strategy for pediatric development as well as potential business development opportunities, including the potential to accommodate expedited development needs
• Provide global regulatory expertise in support of the development, review, and approval of cross-functionally developed strategies and documents intended to enable clinical trials and marketing authorizations for pediatric programs
• Plan, lead, develop, and review regulatory submissions, such as clinical trial applications, marketing applications, and life-cycle management submissions for pediatric programs
• Plan and lead health authority interactions, as needed, including the development and/or review of associated documents
• Ensure adherence to current regulations associated with regulatory activities
• Develop and provide oversight of direct report(s) within the regulatory strategy team

What You Bring

• Bachelor’s degree in life-sciences or related scientific discipline required; advanced degree (PhD, PharmD, or MS) preferred
• Director: 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry
• Sr Director: 15+ years of experience in Regulatory Affairs within the biopharmaceutical industry
• 7+ years of experience with pediatric plans (both in US and EU)
• Experience leading preparations for health authority interactions and development of briefing documents
• 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
• Pioneered ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others
• Experience managing individuals

Work Location

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings.

What We Will Give You

• 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. When you’re at your best, we’re at our best.
• 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 and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.