35 cmc mature products regulatory manager jobs found

Wabtec It's not just about your career or job title... It's about who you are and the impact you will make on the world. Because whether it's for each other or our customers, we put People First. When our people come together, we Expand the Possible and continuously look for ways to improve what we create and how we do it. If you are constantly striving to grow, you're in good company. We are revolutionizing the way the world moves for future generations, and we want someone who is ready to move with us. Who will you be working with? It's not just about your career or job title... It's about who you are and the impact you will make on the world. Because whether it's for each other or our customers, we put People First. When our people come together, we Expand the Possible and continuously look for ways to improve what we create and how we do it. If you are constantly striving to grow, you're in good company. We are revolutionizing the way the world moves for future...

Merck Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Large Molecule Science and Technology (LMS&T) Measles, Mumps, Rubella, Varicella and Sterile Diluent (MMRV+SD) Vaccine Technical Product Leadership (TPL) is seeking a highly motivated person for the role of Specialist, Vaccine Technical Product Leadership.This role will provide manufacturing science and technology support across the MMRV+SD vaccine sites with a focus on drug substance. The manufacturing sites include West Point, PA and Durham, NC. MMRV+SD Technical Product Leadership is a customer-focused Above-Site technical support group with the primary focus to partner with key business units and customers to identify and implement innovative technical solutions and operational improvements that promote both process and supply chain robustness across the lifecycle of the product. The Specialist,...

Merck Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Large Molecule Science and Technology (LMS&T) Measles, Mumps, Rubella, Varicella and Sterile Diluent (MMRV+SD) Vaccine Technical Product Leadership (TPL) is seeking a highly motivated person for the role of Specialist, Vaccine Technical Product Leadership.This role will provide manufacturing science and technology support across the MMRV+SD vaccine sites with a focus on drug substance. The manufacturing sites include West Point, PA and Durham, NC. MMRV+SD Technical Product Leadership is a customer-focused Above-Site technical support group with the primary focus to partner with key business units and customers to identify and implement innovative technical solutions and operational improvements that promote both process and supply chain robustness across the lifecycle of the product. The Specialist,...

Fidelity Investments Job Description: Please Note: We are unable to consider visa sponsorship for this role. The Save and Lend product area within Cash Solutions is seeking an accomplished Product Leader to lead the Cash Management Account (CMA) team. This role is pivotal in driving digital experiences and delivering committed outcomes by partnering across multiple business units. You will work with the delivery team to execute delivery of product features and releases aligned to the integrated CMA and mobile experience roadmap. This role requires leading cash management web experience and working closely with other digital experience owners for mobile experience. This role reports to the Group Product Leader (GPL), Specialty Saving and Lending. The Value You Deliver As part of this leadership role, some key responsibilities will include: Manage and execute product roadmap, influence, inform and align product strategies with partners Lead product planning...

Fidelity Investments Job Description: Please Note: We are unable to consider visa sponsorship for this role. The Save and Lend product area within Cash Solutions is seeking an accomplished Product Leader to lead the Cash Management Account (CMA) team. This role is pivotal in driving digital experiences and delivering committed outcomes by partnering across multiple business units. You will work with the delivery team to execute delivery of product features and releases aligned to the integrated CMA and mobile experience roadmap. This role requires leading cash management web experience and working closely with other digital experience owners for mobile experience. This role reports to the Group Product Leader (GPL), Specialty Saving and Lending. The Value You Deliver As part of this leadership role, some key responsibilities will include: Manage and execute product roadmap, influence, inform and align product strategies with partners Lead product planning...

Point32Health, Inc. Who We Are Point32Health is a leading not-for-profit health and well-being organization dedicated to delivering high-quality, affordable healthcare. Serving nearly 2 million members, Point32Health builds on the legacy of Harvard Pilgrim Health Care and Tufts Health Plan to provide access to care and empower healthier lives for everyone. Our culture revolves around being a community of care and having shared values that guide our behaviors and decisions. We've had a long-standing commitment to inclusion and equal healthcare access and outcomes, regardless of background; it's at the core of who we are. We value the rich mix of backgrounds, perspectives, and experiences of all of our colleagues, which helps us to provide service with empathy and better understand and meet the needs of the communities where we serve, live, and work. We enjoy the important work we do every day in service to our members, partners, colleagues and communities. Learn more about...

Point32Health, Inc. Who We Are Point32Health is a leading not-for-profit health and well-being organization dedicated to delivering high-quality, affordable healthcare. Serving nearly 2 million members, Point32Health builds on the legacy of Harvard Pilgrim Health Care and Tufts Health Plan to provide access to care and empower healthier lives for everyone. Our culture revolves around being a community of care and having shared values that guide our behaviors and decisions. We've had a long-standing commitment to inclusion and equal healthcare access and outcomes, regardless of background; it's at the core of who we are. We value the rich mix of backgrounds, perspectives, and experiences of all of our colleagues, which helps us to provide service with empathy and better understand and meet the needs of the communities where we serve, live, and work. We enjoy the important work we do every day in service to our members, partners, colleagues and communities. Learn more about...

Biogen About This Role Directly accountable to manage and oversee all meetings and congresses for their assigned business unit(s) internal stakeholders and external stakeholders. As a senior manager, the role is accountable to the most high-touch, complex projects, many of which are working directly with the president of BNA and/or the North American Leadership Team. Their accountability includes and is not limited to understanding the business units, products and all associated environmental factors, incorporate meeting management best practices for both virtual and live meetings or congresses and to be in compliance with all Biogen corporate, financial, legal, and regulatory and travel policies and controls. This knowledge will better support their ability to execute strategic meeting management elements to reduce overall meeting cost while improving the stakeholder (both meeting host and participant) experience. The senior manager will also mentor and train meeting and...

Who we are Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients, and we've built a promising pipeline centered around our core therapeutic areas which include neuroscience, immunology, and immuno-oncology. We are continually developing patient-centric solutions and significantly growing both our generic, biosimilar, and innovative medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth! The opportunity As one of the key leadership roles...

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 Physiochemical Testing group strives to deliver creative medicines to patients through performance fundamental chemical, physical and structural testing within a GxP-compliant QC laboratory to support preclinical and clinical production as well as commercial launch....

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 Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes but is not limited to the...

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 Clinical Trial Physician (CTP), Director, sits within Clinical Development and is responsible for contributing to the design and implementation of the clinical development plan, working closely with Disease Area Head, Clinical Development Lead, Clinical Scientist. and...

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 Teva’s Global R&D division develops new medicines, devices, and combination products to benefit patients worldwide. Our multidisciplinary team advances biologics and biosimilars. Within Teva, Biologics CMC oversees biologic product development from IND submission...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Director, Supply Chain Management, the Associate Director, Supply Chain Planning will build, lead, and execute end-to-end planning activities across our fast-growing organization. This role is responsible for developing and executing robust supply plans, ensuring supply continuity, and supporting strategic business objectives across global external manufacturing and partner networks. The ideal candidate brings deep pharmaceutical supply planning experience, exceptional attention to detail, strong cross functional partnership, and hands-on experience with advanced...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Director, Supply Chain Management, the Associate Director, Supply Chain Planning will build, lead, and execute end-to-end planning activities across our fast-growing organization. This role is responsible for developing and executing robust supply plans, ensuring supply continuity, and supporting strategic business objectives across global external manufacturing and partner networks. The ideal candidate brings deep pharmaceutical supply planning experience, exceptional attention to detail, strong cross functional partnership, and hands-on experience with advanced...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary: Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk assessment and decision...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary: Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk assessment and decision...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Principal Scientist? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will hold work closely with the CDT Lead and other Clinical Representatives in performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs. Main Responsibilities: 1 Contribute to the scientific development of clinical programs and individual clinical studies in alignment with the clinical development plan within the assigned therapeutic area. 2...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Principal Scientist? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will hold work closely with the CDT Lead and other Clinical Representatives in performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs. Main Responsibilities: 1 Contribute to the scientific development of clinical programs and individual clinical studies in alignment with the clinical development plan within the assigned therapeutic area. 2...

Point32Health, Inc. Who We Are Point32Health is a leading not-for-profit health and well-being organization dedicated to delivering high-quality, affordable healthcare. Serving nearly 2 million members, Point32Health builds on the legacy of Harvard Pilgrim Health Care and Tufts Health Plan to provide access to care and empower healthier lives for everyone. Our culture revolves around being a community of care and having shared values that guide our behaviors and decisions. We've had a long-standing commitment to inclusion and equal healthcare access and outcomes, regardless of background; it's at the core of who we are. We value the rich mix of backgrounds, perspectives, and experiences of all of our colleagues, which helps us to provide service with empathy and better understand and meet the needs of the communities where we serve, live, and work. We enjoy the important work we do every day in service to our members, partners, colleagues and communities. Learn more about...