- 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.
- 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
- Experience in Advisory Committee
- Experience in cell and gene therapy
-
Business Development and Strategy Associate
5 days ago
LifeStance Health Boston, United StatesAt LifeStance Health, we strive to help individuals, families, and communities with their mental health needs. Everywhere. Every day. It's a lofty goal; we know. But we make it happen with the best team in mental healthcare. · Thank you for taking the time to explore a career wi ...
-
Corporate Development and Strategy Associate
1 week ago
RapidSOS Boston, United StatesCorporate Development & Strategy Associate · In the time it takes you to read this job description, RapidSOS will have handled ~1,380 emergencies. · At RapidSOS, we are committed to using technology to build a safer, stronger future and working together to save lives. We're in ...
-
Gordon Brothers Careers Boston, United StatesJob Summary · Gordon Brothers is looking for a Business Development & Strategy Analyst to help inform our unique suite of product solutions and enterprise client service model. The analyst will collaborate across Gordon Brothers to inform business decisions, drive deal strategies ...
-
AstraZeneca Boston, United StatesDirector, 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 ...
-
Editorial Director
6 days ago
Boston Consulting Group Boston, United StatesWHAT YOU'LL DO · BCG is looking for an experienced editorial strategist to lead its content program on artificial intelligence. The editorial strategist will work closely with BCG experts and external thought leaders to ensure the firm's perspectives on AI—in particular, its imp ...
-
Validation Maintenance Manager
1 week ago
Takeda Pharmaceuticals Boston, United StatesBy 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 sub ...
-
Validation Maintenance Manager
2 days ago
Takeda Pharmaceutical Company Ltd Boston, United StatesBy 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 subm ...
-
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Nephrology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategy across the current ...
-
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Hematology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategies for the first FDA ...
-
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Pain within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategies across the current and ...
-
Director of Revenue Management
1 week ago
Five Star Quality Care, Inc. Boston, United StatesKey Responsibilities · The Opportunity · The Director of Revenue Management reports directly to the Office of the CEO and is responsible for defining, developing, and delivering a comprehensive revenue management program that drives rate governance, efficiency, that maximizes rev ...
-
Alexion Pharmaceuticals, Inc. Boston, United StatesAt Alexion, AstraZeneca Rare Disease, we are innovators, leaders, and collaborators. At the heart of everything we do is an intense desire to pursue the toughest challenges and truly change the world for people living with rare and devastating diseases. · Alexion's Global Marketi ...
-
BioSpace Boston, United StatesJob Details · 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 inf ...
-
Clinical Development Senior Medical Director
1 week ago
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: · The Senior Medical Director will define the clinical development strategy of an asset, work with cross-functional multidisciplinary teams to define overall asset strategy as well as clinical trials strategy, design and execution, and may serve ...
-
AstraZeneca PLC Boston, United StatesDo you have leadership skills and an in depth knowledge within Regulatory Affairs? Do you want to work on innovative projects of importance for our early Respiratory and Immunology portfolio? · At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and ...
-
Drug Development Project Manager- Director
6 days ago
Argenx SE Boston, United StatesPURPOSE OF THE FUNCTION · At argenx, distinction is made between project teams driving asset (molecule) strategy development and high level execution and those driving indication strategy development and execution within boundaries set by the former. Early Development Strategy Te ...
-
Director, US Heme Marketing Patient Lead
1 week ago
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · Director, US Heme Marketing Patient Lead · Location: Boston, MA (3 days onsite, 2 days remote weekly) · Vertex currently operates at the forefront of rare disease scientific innovation and has successfully developed and commercialized multiple breakthrough medic ...
-
Associate Director, Group Medicare Sales
1 week ago
BlueCross and BlueShield of Massachusetts Boston, United States Full timeReady to help us transform healthcare? Bring your true colors to blue. · Reporting to the SVP, Sales & Client Management, the Director, Group Medicare Sales, is an integral member of the leadership team-driving BCBSMA's purposeful re-entry into the Group Medicare Advantage Market ...
-
BioSpace Boston, United StatesJob Details · 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 inf ...
-
Director, Medical Affairs
1 week ago
Verve Therapeutics Inc Boston, United StatesThe Position · The Director of medical affairs will be responsible for contributing to the overall medical affairs strategy and executing tactical plans. Priority activities include publications and medical communications, scientific congress execution, internal training material ...
Director, Global Regulatory Affairs, Development Strategy - Boston, United States - AstraZeneca
Description
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:
You will need to have:
We would prefer for you to have:
Date Posted
11-Apr-2024Closing 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 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.