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35 director global regulatory affairs jobs found

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Alexion
Mar 28, 2023
Associate Director, Global Regulatory Affairs Development Strategy
Alexion Boston, MA, USA
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized...
Alexion
Mar 28, 2023
Executive Director, Global Regulatory Affairs TA Strategy Lead - Neurology
Alexion Boston, MA, USA
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Director, Global Regulatory Affairs Labeling Lead
Takeda Pharmaceutical Company Ltd Boston, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Director, Global Regulatory Affairs - GI
Takeda Pharmaceutical Company Ltd Boston, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Associate Director, Global Regulatory Affairs Development - GI
Takeda Pharmaceutical Company Ltd Cambridge, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Associate Director, Global Regulatory Affairs - CMC - Small Molecules
Takeda Pharmaceutical Company Ltd Lexington, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Associate Director, Global Regulatory Affairs - CMC - Small Molecules
Takeda Pharmaceutical Company Ltd Cambridge, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Associate Director, Global Regulatory Affairs - CMC - Small Molecules
Takeda Pharmaceutical Company Ltd Boston, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Associate Director, Global Regulatory Affairs - CMC - BioLogics
Takeda Pharmaceutical Company Ltd Lexington, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Associate Director, Global Regulatory Affairs - CMC - BioLogics
Takeda Pharmaceutical Company Ltd Boston, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Associate Director, Global Regulatory Affairs - CMC
Takeda Pharmaceutical Company Ltd Lexington, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Senior Manager/Associate Director, Global Regulatory Affairs - Marketed Products
Takeda Pharmaceutical Company Ltd Cambridge, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Takeda Pharmaceutical Company Ltd
Mar 09, 2023
Senior Manager/Associate Director, Global Regulatory Affairs - Oversight
Takeda Pharmaceutical Company Ltd Boston, MA, USA
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver  Better Health and a Brighter Future  to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color,...
Otsuka
Mar 09, 2023
Director, Global Regulatory Affairs Strategy
Otsuka Remote
At Otsuka, we defy limitation, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology. Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is...
Vertex
Feb 23, 2023
Director, Global Regulatory Affairs - Strategy
Vertex Boston, MA, USA
Vertex is a global biotechnology company that invests in scientific innovation. Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) – a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney disease. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive...
Vertex
Feb 23, 2023
Associate Director/Director, Global Regulatory Affairs Strategy - DMD
Vertex Boston, MA, USA
Vertex is a global biotechnology company that invests in scientific innovation. Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) – a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney disease. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive...
Eisai
Jan 31, 2023
Director, Global Regulatory Affairs - Neurology
Eisai Woodcliff Lake, NJ, USA
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity,...
Baxter
Mar 21, 2023
IT Director, Global Patient Safety - Medical/Clinical & Regulatory Affairs
Baxter Deerfield, IL, USA
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world. Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
GlaxoSmithKline
Mar 14, 2023
Full time
Technical Writing Director, CMC Global Regulatory Affairs
GlaxoSmithKline Waltham, MA, USA
We discover, make and market healthcare products; and we aim to bring them to as many people as possible. Find out how we make this happen and what career opportunities there could be for you - from research and development through to supplying products to those who need them. As a business, we are supporting global efforts to tackle the COVID-19 pandemic and protecting the safety of our people by following local government advice and guidance. We are still hiring to ensure that we can continue to supply our medicines, vaccines and products to our patients and consumers all over the world. You can learn more about our recruitment practices  here . Some of our roles are inundated with applications at this time, so response times may be slower than usual. We appreciate your patience, stay safe and look after yourselves. From newly qualified doctors to experts in their field, we offer physicians the chance to have a number of different roles at every stage of their...
GlaxoSmithKline
Mar 14, 2023
Full time
Manager/Associate Director, Therapeutic Group - Global Regulatory Affairs
GlaxoSmithKline Collegeville, PA, USA
We discover, make and market healthcare products; and we aim to bring them to as many people as possible. Find out how we make this happen and what career opportunities there could be for you - from research and development through to supplying products to those who need them. As a business, we are supporting global efforts to tackle the COVID-19 pandemic and protecting the safety of our people by following local government advice and guidance. We are still hiring to ensure that we can continue to supply our medicines, vaccines and products to our patients and consumers all over the world. You can learn more about our recruitment practices  here . Some of our roles are inundated with applications at this time, so response times may be slower than usual. We appreciate your patience, stay safe and look after yourselves. From newly qualified doctors to experts in their field, we offer physicians the chance to have a number of different roles at every stage of their...
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