Director, Regulatory Strategy (Pediatrics)

Director, Regulatory Strategy (Pediatrics)

Who we are:

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have built. To learn more, visit www.agios.com and follow Agios on LinkedIn and X.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic 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, 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 pediatric strategy 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
• Engage with Regulatory Authorities on project-related matters
• Ensure adherence to current regulations associated with regulatory activities

What you bring:

• Bachelor’s degree in life-sciences or related scientific discipline required; advanced degree (PhD, PharmD, or MS) preferred
• 10+ 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
• Proven ability to manage multiple projects, identify and resolve regulatory issues

• Strong interpersonal skills and the ability to effectively work with others

Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

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. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description..

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.

  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.

• 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. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• 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.
• The current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.