Agios Pharmaceuticals
Sr. Manager, Regulatory Operations
Agios Pharmaceuticals, Cambridge, Massachusetts, us, 02140
Senior Manager, Regulatory Operations
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 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
Senior Manager of Regulatory Operations
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. The
Senior Manager of Regulatory Operations
is responsible for submission management activities and regulatory information management for global applications. This role ensures compliance with evolving global health authority/ICH regulations and guidelines for electronic submission. Additional opportunity to support our Agios Review Committee in the coordination of the review of promotional and non-promotional materials.
What you will do: Partner with Regulatory Affairs Lead(s) to plan and prepare global health authority submissions. Manage submission deliverables, according to timelines, within Veeva RIM; ensure accuracy (advanced editing/formatting support of submission documents and document-level publishing). Oversee timely transmittal of submissions to global health authorities, coordinating activities with external publishing vendor. Archive health authority communications and maintain health authority question and commitment records within Veeva RIM. Plan, prepare and transmit OPDP submissions as needed. Support and partner with Regulatory and cross-functional team members to ensure compliance with and provide guidance on submission standards and processes. Ensure strong communication to identify and address challenges and opportunities for efficiencies. Lead and contribute to Regulatory Operations initiatives (process changes and system implementations/enhancements); recommend and help implement associated process improvements. Support Agios Review Committee (ARC) in coordination activities (review of promotional and non-promotional materials) as needed. What you bring:
Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred. 6 years of Regulatory Operations experience in a biotech/pharmaceutical industry. Extensive experience with Microsoft Word and Adobe Acrobat (experience with StartingPoint templates and TRS/ISI Toolbox preferred). Experience using Regulatory Information Management System (RIM) (Veeva RIM experience preferred). Demonstrated knowledge of current CTD/eCTD format and regulatory submission requirements. Experience compiling/publishing global eCTD submissions. Experience with Veeva PromoMats preferred. Ability to work independently as well as part of a team and with external partners. Strong attention to detail and the ability to multi-task in 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. Excellent organizational and communication skills, both written and verbal. Positive attitude and proactive. 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.
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 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
Senior Manager of Regulatory Operations
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. The
Senior Manager of Regulatory Operations
is responsible for submission management activities and regulatory information management for global applications. This role ensures compliance with evolving global health authority/ICH regulations and guidelines for electronic submission. Additional opportunity to support our Agios Review Committee in the coordination of the review of promotional and non-promotional materials.
What you will do: Partner with Regulatory Affairs Lead(s) to plan and prepare global health authority submissions. Manage submission deliverables, according to timelines, within Veeva RIM; ensure accuracy (advanced editing/formatting support of submission documents and document-level publishing). Oversee timely transmittal of submissions to global health authorities, coordinating activities with external publishing vendor. Archive health authority communications and maintain health authority question and commitment records within Veeva RIM. Plan, prepare and transmit OPDP submissions as needed. Support and partner with Regulatory and cross-functional team members to ensure compliance with and provide guidance on submission standards and processes. Ensure strong communication to identify and address challenges and opportunities for efficiencies. Lead and contribute to Regulatory Operations initiatives (process changes and system implementations/enhancements); recommend and help implement associated process improvements. Support Agios Review Committee (ARC) in coordination activities (review of promotional and non-promotional materials) as needed. What you bring:
Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred. 6 years of Regulatory Operations experience in a biotech/pharmaceutical industry. Extensive experience with Microsoft Word and Adobe Acrobat (experience with StartingPoint templates and TRS/ISI Toolbox preferred). Experience using Regulatory Information Management System (RIM) (Veeva RIM experience preferred). Demonstrated knowledge of current CTD/eCTD format and regulatory submission requirements. Experience compiling/publishing global eCTD submissions. Experience with Veeva PromoMats preferred. Ability to work independently as well as part of a team and with external partners. Strong attention to detail and the ability to multi-task in 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. Excellent organizational and communication skills, both written and verbal. Positive attitude and proactive. 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.