Senior Manager/Associate Director, Regulatory Affairs Strategy and Labeling – Remote Position Available In Montgomery, Pennsylvania

Job Description:

Who we are: Agios is a biopharmaceutical company that is fueledby connections. We thrive in a supportive, fun, and flexibleenvironment full of people empowered to bring their whole selves towork. We care deeply about our work, each other, and the patientswho count on us. Our teams cultivate strong bonds with patientcommunities, healthcare professionals, partners and colleagues,which helps us discover, develop and deliver therapies forgenetically defined diseases – and make a bigger difference intheir lives. In the U.S., Agios markets a first-in-class pyruvatekinase (PK) activator for the treatment of hemolytic anemia inadults with PK deficiency. Building on the company’s leadership inthe field of cellular metabolism, Agios is advancing a robustclinical pipeline of investigational medicines with active andplanned programs in alpha- and beta-thalassemia, sickle celldisease, pediatric PK deficiency and MDS-associated anemia.

Theimpact you will make:

Agios Pharmaceuticals is searching for aSenior Manager/Associate Director of Regulatory Affairs Strategyand Labeling to join our growing Regulatory team. The SeniorManager/ Associate Director of Regulatory Affairs Strategy will beresponsible for working cross-functionally across the organizationto develop or contribute to, and execute upon regulatory strategiesto support clinical development plans and to prepare and coordinatecompliant, high quality, nonclinical and clinical global regulatorysubmissions across early development, registration, and life cyclemanagement. This individual will also be responsible for workingcross-functionally across the organization to develop and maintainglobal labeling documents (e.g. CCDS, regional product information,and patient leaflets).

What you will do:

Contribute to and executeupon global regulatory strategy for long-term clinical developmentplans, including the potential to accommodate expedited developmentneeds. Work within cross-functional teams to provide globalregulatory strategy and labeling expertise in support of thedevelopment, review, and approval of strategies and documentsintended to enable clinical trials, marketing authorizations, anddesired labeling. Leading responses to health authority questionson clinical trials, marketing authorization applications, andlabeling. 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 includingdevelopment and review of associated documents. Manage the creationand/or maintenance of global labeling strategy and documents (e.g.

CCDS, regional product information, and patient leaflets). Leadcross-functional labeling teams, facilitating discussions onlabeling strategies and content, and ensuring cross-functionalcollaboration and alignment. Ensure adherence to currentregulations associated with regulatory strategy and regulatorylabeling activities.

What you will bring:

Bachelor’s degree inlife-sciences or related scientific discipline; advanced degreepreferred Must have experience in both Regulatory Affairs strategyand Regulatory Product Information Labeling (e.g. Company Core DataSheet, USPI, SmPC);

Associate Director:

Must have a minimum of 6years in Regulatory Affairs strategy and labeling combined

SeniorManager:

Must have 4 years in Regulatory affairs strategy andlabeling combined Strong demonstration of knowledge of drugdevelopment, FDA, EMA and ICH guidelines and regulations Excellentorganizational and communication skills, both written and verbalAbility to work independently as well as part of a team environmentPositive attitude, energetic and proactive Proven ability to managemultiple projects, identify and resolve regulatory issues Stronginterpersonal skills and the ability to effectively work withothers Concerned that you don’t check off every box in therequirements listed above? Please apply anyway! At Agios, we valueeach other’s differences and recognize that teams thrive wheneveryone brings their unique experiences to the table. We arededicated to building an inclusive, diverse, equitable, andaccessible environment where all employees can bring their wholeselves to work. If you’re excited about this role but your previousexperience doesn’t align perfectly with the job description, westill encourage you to apply. You may be just the right candidatefor this role or another opening!

Work Location:

Location Agnostic:

Work location for this role is based on employees individualpreference. This role has the ability to be either remote in the USor hybrid in our Cambridge Headquarters. Hybrid schedules vary butare generally less than 3 days per week onsite and hybrid employeesare expected to live within commutable distance to our CambridgeHeadquarters. Remote employees work entirely from home except forattending Company sponsored events/ meetings. For employees whochoose to work remotely, travel may be required for certain companyevents commensurate to the above job description.

What we will giveyou:

Deliberate Development. Your professional growth as one of ourtop priorities. Flexibility. We’re all about individual needs. Weembrace different perspectives, work styles, health and wellnessapproaches, care of families and productivity. When you’re at yourbest, we’re at our best. Premium benefits package. We invest in thehealth, wellbeing, and security of our people with a premiumbenefits package that is well-rounded and flexible to help meet thevaried personal and professional needs of every member of our team.

Competitive and equitable performance-based compensation. Thisincludes base salary and both short- and long-term incentives thatare connected to our business strategy and vary based on individualand company performance. The current base salary range for thisposition at the Senior Manager level is expected to be between$127,219 and $190,828 annualized and the current base salary rangefor this position at the Associate Director level is expected to bebetween $149,069 and $223,604 annualized; final salary will bedetermined based on various factors including, but not limited to,years of relevant experience, job knowledge, skills andproficiency, degree/education, and internal comparators.

Competitive performance-based compensation. This includes bothshort- and long-term incentives that are connected to our businessstrategy. Psychological safety. We support an environment offearlessness. We want you to share your ideas, speak candidly andtake data-informed risks to help push the boundaries. Commitment todiversity. We strive to foster a welcoming workplace where everyonecan thrive. We’re continuously looking to improve the inclusivityof our workforce. Commitment to community. We’re an activeparticipant in the communities that surround us – the communitieswhere we live, and the community of people and their loved ones inneed of better treatment options for conditions that are oftenoverlooked.