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National Black MBA Association
Boston, MA, United States
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. We are hirin
Job Source: National Black MBA AssociationAttaineo Search, 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 collabo
Job Source: Attaineo Search, Inc.Moderna
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: ModernaProclinical Staffing
Cambridge, MA, United States
Associate Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA Proclinical is seeking an Associate Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in New Jersey and Massachusetts. Primary Responsibilities: In this role, you will serve as the regulatory lead
Job Source: Proclinical StaffingTakeda 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 PharmaceuticalsBerklee College of Music
Boston, MA, United States
Job Description: Reporting to the Senior Director of Content and Media Strategy, the Director of Content Strategy oversees the production and development of all editorial content and publications, leading the creation and implementation of content strategies and policies across the Berklee organization, including Berklee College of Music, Boston Co
Job Source: Berklee College of MusicIntellia 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.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 determ
Job Source: Intellia Therapeutics, Inc.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:
Developing and directing innovative and effective regulatory strategies in support of specific projects, and across projects in the Alexion portfolio.
Serving as US Strategy lead on assigned programs. Acting as submission sub-team lead for US submissions and is core member of Regulatory Subteam (RST) for assigned programs.
Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.
Representing Alexion as point contact FDA and leading Alexion delegation for regulatory authority meetings.
Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, new marketing authorization applications, etc.
Monitoring the development of new regulatory requirements or guidance documents and advising product teams of the impact on the business or development programs. Providing support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
Ensuring exemplary behavior, ethics and transparency within the company and with regulatory agencies.
You will need to have:
Strong knowledge of US drug development and regulatory policy; excellent scientific and business judgment.
Experience providing US strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
Experience with leading major submissions and FDA meetings
Ability to manage complex issues and coordinate multiple projects simultaneously
Ability to build intra-team relationships and collaborate in a global team environment at all levels of the organization.
Strong interpersonal, and written/verbal communication skills.
Proven track record practicing sound judgment as it relates to risk assessment
Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.
Bachelor’s Degree in a related discipline
We would prefer for you to have:
Experience in Advisory Committee
Experience in cell and gene therapy
Date Posted
11-Apr-2024
Closing Date
30-Dec-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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Email Alert for Director, Labeling Strategy jobs in Boston, MA, United States
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