Location
Cambridge, MA | United States
Job description
Director, 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 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 dynamic Director, Regulatory Affairs - CMC to join our growing 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. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members. The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. Examples include IMPDs, Module 3 of INDs, NDAs, MAAs, and health authority CMC meeting packages (eg, meeting requests, briefing documents, meeting presentations).
What you will do: - Lead project teams to prepare submission-ready CMC documents, including but not limited to clinical trial and marketing applications and amendments, formal meeting requests and briefing documents, and commercial life-cycle management submissions. Responsible for the overall project management to facilitate efficient document development and finalization.
- Serve as Regulatory-CMC lead for all assigned program(s), providing input towards compliant and strategically sound development programs. Represent the Regulatory-CMC function on technical operations and development teams, as assigned. Review and approve CMC technical and GMP documentation, including but not limited to change control and validation reports, for the Regulatory-CMC function as per Agios SOPs.
- Accountable for CMC submission documents; author and/or manage the writing and completion of documents within established timelines and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes through both internal and external writing resources.
- Ensure that deliverables meet all applicable regulations, standards, and guidelines, including US FDA, EMA and ICH Quality guidelines.
- Work and collaborate with Regulatory Affairs team members in designing and maintaining templates and standards for CMC documents in accordance with applicable guidelines and CMC writing best practices.
- Act as the point person to engage and communicate with health authorities on CMC matters, as aligned with internal cross-functional teams and leadership.
What you bring: - B.S. in a scientific discipline, Chemistry degree preferred, advanced degree a plus.
- 14 years relevant CMC pharmaceutical development and regulatory experience.
- Extensive experience in the preparation and oversight of CMC (Module 3) submissions (ie, INDs, IMPDs, NDAs, MAAs). Proven track record of successful resolution of health authority queries.
- Ability to interpret and to clearly and succinctly present complex scientific CMC data, paired with excellent working knowledge of the relevant regulations and guidance.
- Exceptional written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
- Demonstrated organizational skills and ability to prioritize, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.
- Ability to work both collaboratively on a cross-functional team and independently; ability to connect and communicate effectively with team members, leadership, and other stakeholders.
- Experience leading CMC topic interactions with health authorities.
- Proven ability to independently manage multiple projects, to proactively identify and resolve regulatory issues, to appropriately raise issues to management, and to bring an insightful approach to problem solving.
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.
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