Senior Manager/Associate Director, Regulatory Affairs Strategy and Labeling - Remote - Agios Pharmaceuticals

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a Senior Manager/Associate Director of Regulatory Affairs Strategy and Labeling to join our growing Regulatory team. The Senior Manager/ Associate Director of Regulatory Affairs Strategy will be responsible for working cross-functionally across the organization to develop or contribute to, and execute upon regulatory strategies to support clinical development plans and to prepare and coordinate compliant, high quality, nonclinical and clinical global regulatory submissions across early development, registration, and life cycle management. This individual will also be responsible for working cross-functionally across the organization to develop and maintain global labeling documents (e.g. CCDS, regional product information, and patient leaflets).

What you will do:

• Contribute to and execute upon global regulatory strategy for long-term clinical development plans, including the potential to accommodate expedited development needs.
• Work within cross-functional teams to provide global regulatory strategy and labeling expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials, marketing authorizations, and desired labeling.
• Leading responses to health authority questions on clinical trials, marketing authorization applications, and labeling. 
• Plan, lead, develop, and review regulatory submissions, such as clinical trial and marketing authorization applications, pediatric development plans, and life-cycle management submissions.
• Lead preparations for health authority interactions including development and review of associated documents.
• Manage the creation and/or maintenance of global labeling strategy and documents (e.g. CCDS, regional product information, and patient leaflets).
• Lead cross-functional labeling teams, facilitating discussions on labeling strategies and content, and ensuring cross-functional collaboration and alignment.
• Ensure adherence to current regulations associated with regulatory strategy and regulatory labeling activities.

What you will bring:

• Bachelor’s degree in life-sciences or related scientific discipline; advanced degree preferred
• Must have experience in both Regulatory Affairs strategy and Regulatory Product Information Labeling (e.g. Company Core Data Sheet, USPI, SmPC); 
• Associate Director: Must have a minimum of 6 years in Regulatory Affairs strategy and labeling combined
• Senior Manager: Must have 4 years in Regulatory affairs strategy and labeling combined
• 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

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 employees 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.
• 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.
• The current base salary range for this position at the Senior Manager level is expected to be between $127,219 and $190,828 annualized and the current base salary range for this position at the Associate Director level is expected to be between $149,069 and $223,604 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.
• 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.