Kinsley Power Systems
Associate Director, Regulatory CMC
Kinsley Power Systems, Cambridge, Massachusetts, us, 02140
Associate Director, Regulatory Affairs – CMC
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 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
Associate Director 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
Associate Director, Regulatory Affairs CMC
will lead CMC regulatory strategy to support global development and lifecycle. The Associate Director will be responsible for clinical and commercial submissions including, authoring, adjudicating/addressing the review and QC comments, and finalizing the submission documents. This role is accountable for compliance with evolving Quality/CMC regulations and guidelines to support early development, registration, and lifecycle management.
What you will do:
Responsible and accountable for the preparation of submission-ready CMC documents, including clinical trial and marketing applications, formal meeting requests and briefing documents, and commercial life-cycle management submissions.
Responsible for the overall CMC submission development, including planning, authoring, reviewing, and editing as required to meet cross-functional team objectives and timelines.
Serves as Regulatory CMC lead for all assigned program(s), including the development and communication of overall CMC regulatory strategy for internal or partnered programs.
Review and approve CMC technical and GMP documentation for the Regulatory CMC function.
Assess regulatory impact of GMP changes.
Engage with health authorities on CMC matters.
Provide guidance to internal project teams and CMO/CRO partners to ensure regulatory compliance.
What you bring:
B.S. in a scientific discipline, Chemistry degree preferred, advanced degree a plus.
10+ years relevant CMC/Regulatory CMC pharmaceutical industry experience.
Extensive experience in the preparation and oversight of CMC (Module 3) submissions (i.e., INDs, IMPDs, NDAs, MAAs).
Demonstrated expertise in Health Authority CMC guidance (FDA, EMA, Health Canada, etc.) and ability to effectively apply the principles in the authoring of Module 3 documents.
Strong knowledge of the fundamentals of CMC pharmaceutical development.
Experience leading or supporting CMC interactions with health authorities.
Excellent interpersonal, verbal, and written communication skills.
Demonstrated ability to influence.
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.
Excellent organizational and communication skills, both written and verbal.
Positive attitude and proactive.
Strong attention to detail and the ability to multi-task in a fast-paced environment.
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.
#J-18808-Ljbffr
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 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
Associate Director 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
Associate Director, Regulatory Affairs CMC
will lead CMC regulatory strategy to support global development and lifecycle. The Associate Director will be responsible for clinical and commercial submissions including, authoring, adjudicating/addressing the review and QC comments, and finalizing the submission documents. This role is accountable for compliance with evolving Quality/CMC regulations and guidelines to support early development, registration, and lifecycle management.
What you will do:
Responsible and accountable for the preparation of submission-ready CMC documents, including clinical trial and marketing applications, formal meeting requests and briefing documents, and commercial life-cycle management submissions.
Responsible for the overall CMC submission development, including planning, authoring, reviewing, and editing as required to meet cross-functional team objectives and timelines.
Serves as Regulatory CMC lead for all assigned program(s), including the development and communication of overall CMC regulatory strategy for internal or partnered programs.
Review and approve CMC technical and GMP documentation for the Regulatory CMC function.
Assess regulatory impact of GMP changes.
Engage with health authorities on CMC matters.
Provide guidance to internal project teams and CMO/CRO partners to ensure regulatory compliance.
What you bring:
B.S. in a scientific discipline, Chemistry degree preferred, advanced degree a plus.
10+ years relevant CMC/Regulatory CMC pharmaceutical industry experience.
Extensive experience in the preparation and oversight of CMC (Module 3) submissions (i.e., INDs, IMPDs, NDAs, MAAs).
Demonstrated expertise in Health Authority CMC guidance (FDA, EMA, Health Canada, etc.) and ability to effectively apply the principles in the authoring of Module 3 documents.
Strong knowledge of the fundamentals of CMC pharmaceutical development.
Experience leading or supporting CMC interactions with health authorities.
Excellent interpersonal, verbal, and written communication skills.
Demonstrated ability to influence.
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.
Excellent organizational and communication skills, both written and verbal.
Positive attitude and proactive.
Strong attention to detail and the ability to multi-task in a fast-paced environment.
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.
#J-18808-Ljbffr