Manager, Regulatory CMC

Manager, Regulatory Affairs - CMC

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 rare disease – 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 dynamic Manager of Regulatory Affairs - CMC to join our Regulatory Affairs 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 Manager, Regulatory Affairs CMC will be responsible for supporting the team in the management and tracking of clinical and commercial Quality/CMC submissions including authoring support, adjudicating and addressing the review and QC comments, and finalizing the submission documents. This role ensures compliance with evolving regulations and guidelines for provision of compliant and sufficient Quality/CMC information to health authorities.

What you will do:

• Lead the cross-functional team in the development and finalization of Quality/CMC regulatory submission documents.
• Update and maintain planning and tracking files and metrics.
• Manage the development and internal approvals of carton and container labelling (artwork), including translations.
• Partner with the cross-functional team to manage regulatory actions stemming from GMP changes.
• Participate in cross-functional team meetings, ensure follow-up of regulatory action items.
• Author regulatory submissions in collaboration with the cross-functional team.
  
  

What you bring:

• Bachelor’s degree in chemistry or Life Sciences.
• 5+ years of experience in a CMC function (e.g. Analytical, Formulations, QA, QC) or within Regulatory-CMC in the biotech/pharmaceutical industry.
• Sound foundational knowledge of drug development, Quality/CMC guidelines and regulations (eg, FDA, EMA and ICH), and Good Manufacturing Practices (GMP).
• Possess excellent problem-solving abilities.
• Experience with review and/or providing content for Quality/CMC regulatory submissions preferred (eg, Module 3 documents).
• Knowledge of regulations and prior experience in managing carton and container labeling activities preferred.
• Excellent organizational and communication skills, both written and verbal.
• Positive attitude, energetic and proactive.
• Strong attention to detail and the ability to multi-task in a fast-paced environment.
• Strong interpersonal skills and the ability to effectively work individually, within a cross-functional team, as well as with external partners and vendors.
  
  

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.
• 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 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.
  
  

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