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16 director regulatory cmc jobs found

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Vertex
Jul 02, 2025
Director, Regulatory CMC - Cell & Gene Therapy
Vertex Boston, MA, USA
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.
Vertex
Jul 02, 2025
Director, Regulatory CMC - Cell & Gene Therapy
Vertex Boston, MA, USA
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.
Biomarin
Jun 24, 2025
Full time
Director, Regulatory CMC
Biomarin San Rafael, CA, USA
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. 
Horizon Pharmaceutical
Jul 07, 2025
Senior Director, CMC Regulatory Affairs
Horizon Pharmaceutical Lake Forest, IL, USA
Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. Working at Horizon is more than a job – it’s personal. For us, success is measured by the numbers that matter most – the number of lives we touch, the number we change and those we work tirelessly to help save. We’re a team of agile, out-of-the-box thinkers who are inspired to do more because we know we’re a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs. Horizon Core Values & Competencies: Growth Manages Ambiguity Strategic Mindset Demonstrates...
Lilly Pharmaceuticals
Jul 07, 2025
Full time
Senior Director, Global Regulatory Affairs CMC – Synthetic Molecules
Lilly Pharmaceuticals Indianapolis, IN, USA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. 
Lilly Pharmaceuticals
Jul 07, 2025
Full time
Senior Director, Global Regulatory Affairs CMC – Synthetic Molecules
Lilly Pharmaceuticals Indianapolis, IN, USA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. 
Lilly Pharmaceuticals
Jul 07, 2025
Full time
Senior Director, Global Regulatory Affairs CMC – Synthetic Molecules
Lilly Pharmaceuticals Indianapolis, IN, USA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. 
Daiichi Sankyo Company
Jun 30, 2025
Full time
Senior Scientist/Associate Director, Regulatory Affairs CMC
Daiichi Sankyo Company Bernards, NJ, USA
Established in 2006 by the merger of two 100-year-old Japanese pharmaceutical companies, Daiichi Sankyo, Inc. is headquartered in New Jersey. The organization includes U.S. commercial operations and global drug development. We offer a unique blend of an entrepreneurial environment and a collaborative culture, and the innovation that propels us forward comes from all corners of our company. At Daiichi Sankyo, good ideas don't just happen in the lab, but also in conference rooms, at desks and in the field, contributed both by individuals and groups.
AstraZeneca
Jun 30, 2025
Full time
Director, Global Regulatory Affairs CMC
AstraZeneca Boston, MA, USA
At AstraZeneca our mission is to create an inclusive and equitable environment, where people feel they belong. Our ongoing commitment to inclusion and diversity means we’re future proofing our business. It allows us to push the boundaries of science and deliver life-changing medicines to more and more patients around the world.
Alexion
Jun 24, 2025
Full time
Director, Global Regulatory Affairs CMC
Alexion Boston, MA, USA
Working at Alexion is an experience like no other. With a focus on devastating and rare diseases, each endeavor is urgent and every day counts. You’ll have the opportunity to work on one of the most robust and exciting rare disease pipelines in the biopharmaceutical industry, which includes dozens of diverse preclinical programs across a range of therapeutic modalities. Ground-breaking innovation, life-saving therapies and a promising pipeline, all driven by a team with a shared sense of purpose and dedication – that’s Alexion. Join us to achieve the impossible and do what’s never been done before.
Regeneron
Jun 20, 2025
Associate Director CMC Regulatory Affairs
Regeneron Cambridge, MA, USA
At Regeneron, we believe in the power of original thinking. Our company is built on breakthrough ideas; which is why we foster a spirit of openness, and strive to inspire from within. We are collaborative by design and driven by curiosity. Each one of us plays an active role in transforming people’s lives through our work. Regeneron’s people make us who we are, and we are truly more than a company – we’re a community. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the...
Regeneron
Jun 20, 2025
Associate Director CMC Regulatory Affairs
Regeneron Cambridge, MA, USA
At Regeneron, we believe in the power of original thinking. Our company is built on breakthrough ideas; which is why we foster a spirit of openness, and strive to inspire from within. We are collaborative by design and driven by curiosity. Each one of us plays an active role in transforming people’s lives through our work. Regeneron’s people make us who we are, and we are truly more than a company – we’re a community. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the...
Novartis
Jun 18, 2025
Full time
Regulatory Affairs CMC Associate Director (Oncology)
Novartis East Hanover, NJ, USA
At Novartis US, our mission is to reimagine medicine and discover new ways to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. 
Ironwood Pharmaceutical
Jun 12, 2025
Full time
Director, Global Regulatory Affairs (GRA) – CMC
Ironwood Pharmaceutical Boston, MA, USA
Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients.
Ironwood Pharmaceutical
Jun 12, 2025
Full time
Director, Global Regulatory Affairs (GRA) – CMC
Ironwood Pharmaceutical Boston, MA, USA
Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients.
Gilead
Jun 10, 2025
Full time
Director, CMC Regulatory Affairs – Biologics
Gilead Foster City, CA, USA
As a worldwide workforce we are deeply committed to helping solve some of today’s biggest healthcare challenges, offering solutions for patients suffering from life-threatening diseases such as HIV/AIDS, liver disease, oncology and respiratory disease. At our core lies a corporate culture committed to science and patients, and an employee environment that fosters innovation, diversity and a commitment to the personal and professional development of all our colleagues. As we grow, we are continually looking to connect with outstanding individuals who are interested in joining our intellectually stimulating and socially responsible team. Successful colleagues at Gilead come from all backgrounds, have a range of perspectives and thrive in an agile and rapidly evolving environment.
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