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Moderna Therapeutics Inc.
Cambridge, MA, United States
The Role: Moderna Therapeutics is seeking a Sr. Manager of Regulatory Strategy based in Cambridge headquarters. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug
Job Source: Moderna Therapeutics Inc.AstraZeneca
Boston, MA, United States
Director, Global Regulatory Affairs, Development Strategy This is what you will do: Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. You will be responsible for: Devel
Job Source: AstraZenecaLantheus
Bedford, MA, United States
Description Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organiza
Job Source: LantheusLantheus
Bedford, MA, United States
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provi
Job Source: LantheusTakeda Pharmaceuticals
Boston
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Source: Takeda PharmaceuticalsModerna
Cambridge, MA, United States
The Role: Moderna Therapeutics is seeking an Assoc. Director of Regulatory Labeling to support current and existing programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward-looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling f
Job Source: ModernaIntellia Therapeutics, Inc.
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determ
Job Source: Intellia Therapeutics, Inc.Intellia Therapeutics, Inc.
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determin
Job Source: Intellia Therapeutics, Inc.Boston, MA, United States
Job Description
Position Title: Senior Manager, Regulatory Core Labeling Strategy
Location: Boston, Massachusetts (Remote)
Overview:
We are seeking a dedicated and experienced Senior Manager for Core Labeling Strategy to lead and manage the labeling process and development for an assigned therapeutic area/portfolio. The individual will collaborate with internal teams, represent the organization in industry groups, and potentially manage direct reports within the labeling team, ensuring the company's compliance with relevant laws and regulations.
Key Responsibilities:
Lead the preparation, review, and approval of global and territorial labeling documentation to support regulatory filings for international regulatory agencies.
Develop labeling strategies in alignment with overall regulatory strategies, providing expertise on regulations, internal processes, and competitor profiles.
Establish partnerships with project leads and regulatory matrix, interfacing with senior management on business strategy and labeling content.
Collaborate with an aligned Regulatory Strategist and other stakeholder teams to lead all labeling aspects for the defined portfolio.
Evaluate the principles and data upon which labeling statements are based, ensuring their clinical relevance and regulatory acceptance.
Work with Global Product Safety and Risk Management to verify and agree on the content of PI texts, escalating issues to the Global Labeling Committee (GLC) when necessary.
Stay informed on competitor labels, external labeling trends, agency requirements, and negotiate the resolution of complex regulatory and scientific issues.
Represent the organization in various industry groups and at events sponsored by EMA or FDA.
Potentially manage, recruit, and motivate within the Labeling team, contributing to the leadership of the organization and driving effective governance through GLC processes.
Requirements
A minimum of a Bachelor's degree in science, Pharmacy, or a related field; a Master's Degree, PharmD, or PhD is preferred.
A combination of experience and/or education will be considered.
7-10 years of experience with 5 or more years in Labeling and Labeling development.
Prior leadership experience or willingness to lead others.
In-depth knowledge of labeling, GLC requirements/processes, and EU/US regulations.
Highly developed interpersonal, presentation, and communication skills, with the ability to influence effectively in a matrixed, cross-functional team environment.
Ability to interpret comprehensive research documents, write scientific reports, and present to high levels of the organization.
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Email Alert for Sr. Manager, Regulatory, Core Labeling Strategy jobs in Boston, MA, United States
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