94 global regulatory affairs director jobs found

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ironwood Pharmaceuticals Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. Purpose/Summary: Reporting to the Head of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The Regulatory Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs, will be responsible to develop and manage detailed regulatory project plans for major global dossiers. The Director that fills this highly visible role will work in a...

GSK Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharmaceutical company? If so, this role may be for you! As the Director Clinical Sciences, Oncology, you will be responsible for building up the current Oncology development team, including recruitment of clinical scientists, and developing and leading GSK medium and long-term oncology development strategies for GSK's oncology pipeline. You will work closely with the Global Oncology Research and Development and Medical Affairs to ensure that the oncology clinical team have the highest quality capabilities and expertise. You will also ensure the optimal launch of new products and appropriate optimal patient use of currently available GSK Medicines through leadership and collaboration. In this role you will: Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout...

GSK Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharmaceutical company? If so, this role may be for you! As the Director Clinical Sciences, Oncology, you will be responsible for building up the current Oncology development team, including recruitment of clinical scientists, and developing and leading GSK medium and long-term oncology development strategies for GSK's oncology pipeline. You will work closely with the Global Oncology Research and Development and Medical Affairs to ensure that the oncology clinical team have the highest quality capabilities and expertise. You will also ensure the optimal launch of new products and appropriate optimal patient use of currently available GSK Medicines through leadership and collaboration. In this role you will: Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout...

Biogen About This Role The Fluid Biomarker group is seeking a highly motivated, experienced individual to join a dynamic team engaged in the implementation of biomarkers to support clinical therapeutic development. This role is required to oversee and support the development, implementation, and execution of biomarker strategies in support of programs across the Neurodegeneration and Neuromuscular portfolio. The successful candidate will have a proven track record of strong leadership developing and delivering on biomarker strategies across all stages of drug development, including late-stage clinical development. Excellent strategic thinking, communication and collaboration skills are essential. What You'll Do In collaboration with other members of the biomarker team, develop and implement biomarker strategies for programs in clinical development, with an emphasis on pivotal/Phase 3 and marketed programs. Provide guidance and direction to fluid members of the...

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!   Remote opportunitiy - Open to candidates anywhere in the greater United States   SUMMARY: The Director, US Regulatory Affairs Alliance and Commercialization, will oversee and lead regulatory affairs strategy for our alliance partnership products and commercialization efforts, requiring knowledge and expertise of regulations across scientific messaging, promotional compliance, global regulatory strategic labeling and regulatory strategy. This role will lead...

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!   Remote opportunity - open to candidates anywhere in the greater United States   SUMMARY: The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development of end- to- end (e2e) labelling process for development of new and/or revised labels, as well as strategic labelling development for pipeline assets. Will champion the implementation of label as driver process from early development through regulatory approval. The individual...

Boston Consulting Group (BCG) Locations : Boston | Atlanta Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transformation-inspiring complex change, enabling organizations to grow, building competitive advantage, and driving bottom-line impact. To succeed, organizations must blend digital and human capabilities. Our diverse, global teams bring deep industry and functional expertise and a range of perspectives to spark change. BCG delivers solutions through leading-edge management consulting along with technology and design, corporate and digital ventures-and business purpose. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, generating results that allow our clients to thrive. What You'll Do You...

Boston Consulting Group (BCG) Locations : Boston | Atlanta Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transformation-inspiring complex change, enabling organizations to grow, building competitive advantage, and driving bottom-line impact. To succeed, organizations must blend digital and human capabilities. Our diverse, global teams bring deep industry and functional expertise and a range of perspectives to spark change. BCG delivers solutions through leading-edge management consulting along with technology and design, corporate and digital ventures-and business purpose. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, generating results that allow our clients to thrive. What You'll Do You...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity Responsible for the design and implementation of PMX strategy on the program level; the construction, validation, and implementation of disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity Director, Clinical Development is responsible for the development, execution and management of several clinical programs worldwide across all phases of clinical research. The individual will oversee study teams and will be responsible for leading cross-functional teams in...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The individual will serve as a strategic business partner and compliance advisor to all global R&D functions (which includes Global Medical Affairs, Global Pharmacovigilance, and Global Health Economics Values and Outcomes) as well as the US Medical Affairs function....

Lundbeck Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! Remote opportunitiy - Open to candidates anywhere in the greater United States SUMMARY: The Director, US Regulatory Affairs Alliance and Commercialization, will oversee and lead regulatory affairs strategy for our alliance partnership products and commercialization efforts, requiring knowledge and expertise of regulations across scientific messaging, promotional compliance, global regulatory strategic labeling and regulatory strategy. This role will...

Alkermes, Inc. Reporting to the Senior Regional Director, the District Business Leader (DBL) will be responsible for achieving business objectives by leading a team of Territory Business Managers (TBMs) in the successful promotion of ARISTADA, LYBALVI, and future neuroscience pipeline products & services. This will be accomplished by successfully leading, coaching and developing a diverse, high-performing sales team to exceed sales goals within an assigned geographic area. Key attributes necessary for success will be the ability to inspire and motivate a high performing, results oriented team, possess a strategic perspective on managing business opportunities and as needed, execute efficient performance management practices. DBLs will need to provide clear direction and coaching, work collaboratively in the field with the sales team to assist in identifying needs and opportunities and as needed execute successful sales meetings. In addition, the DBL will establish high work...

Alkermes, Inc. Reporting to the Senior Regional Director, the District Business Leader (DBL) will be responsible for achieving business objectives by leading a team of Territory Business Managers (TBMs) in the successful promotion of ARISTADA, LYBALVI, and future neuroscience pipeline products & services. This will be accomplished by successfully leading, coaching and developing a diverse, high-performing sales team to exceed sales goals within an assigned geographic area. Key attributes necessary for success will be the ability to inspire and motivate a high performing, results oriented team, possess a strategic perspective on managing business opportunities and as needed, execute efficient performance management practices. DBLs will need to provide clear direction and coaching, work collaboratively in the field with the sales team to assist in identifying needs and opportunities and as needed execute successful sales meetings. In addition, the DBL will establish high work...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Alkermes, Inc. Reporting to the Senior Regional Sales Director (SRD), the VIVITROL District Business Leader (DBL) will be responsible for the leadership of a team of Territory Business Managers (TBM's) representing a long acting injectable therapy for the treatment of addiction covering the California District. Key attributes necessary for success will be the ability to identify and hire an exceptional sales team, possess a strategic perspective as well as inspire and motivate a high performing, results oriented team. DBL's will need to provide clear direction and coaching, work collaboratively in the field with the sales team to assist in identifying needs and opportunities and as needed execute successful sales meetings. In addition, the DBL will establish high work standards and assure that the team works in accordance with all company policies. Responsibilities Key responsibilities include: Play a key role in identifying, recruiting, coaching and retaining top...