Director, CMC Regulatory Affairs
Found in: beBee S US - 1 week ago
- We are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.
- The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan’s oncology cell therapy products, from preclinical to eventual commercial stages.
- The ideal candidate should have relevant experience in CMC regulatory activities for investigation cell therapy products in oncology, and enjoy fast-paced, collaborative and vibrant startup culture.
- Develop and execute global CMC regulatory strategies for oncology cell therapy products in alignment with the company’s objectives and regulatory requirements
- Provide CMC regulatory expertise and input to cross-functional teams, such as manufacturing, quality, research, and clinical development, to ensure alignment and compliance with CMC regulatory requirements
- Minimum of 10 years of experience in CMC regulatory affairs in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role
- Experience in developing and implementing global CMC regulatory strategies for cell therapy or gene therapy products is highly preferred
- Experience in preparing and submitting CMC sections of INDs, BLAs, and amendments for cell therapy or gene therapy products is required
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Director, CMC Regulatory Affairs
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Tscanrx Full timeWe are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan's oncology...
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Director, CMC Regulatory Affairs
Found in: Talent US C2 - 3 weeks ago
Waltham, United States Alkermes Full timeOverview: Great Science. Deep Compassion. Real Impact. Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases....
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Manager/Senior Manager, CMC Regulatory Affairs
Found in: beBee S US - 1 week ago
Waltham, United States Alkermes, Inc. Full timeGreat Science.Deep Compassion.Real Impact. Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio...
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Manager/Senior Manager, CMC Regulatory Affairs
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Alkermes, Inc. Full timeGreat Science.Deep Compassion.Real Impact.Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction.We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio...
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Director, Regulatory Affairs
Found in: beBee S US - 1 week ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
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Director, Regulatory Affairs
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
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Director of Regulatory Affairs
2 weeks ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
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Director, CMC Bioconjugation
Found in: Jooble US O C2 - 3 weeks ago
Waltham, MA, United States Dyne Tx Full timeDirector, CMC Bioconjugation & External Manufacturing With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) and Duchenne muscular...
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Senior Director, Clinical Regulatory Affairs
20 hours ago
Waltham, United States Dragonfly Therapeutics Full timeSenior Director, Regulatory Affairs Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility of this role is to develop regulatory strategies for both non-clinical and clinical aspects,...
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Senior Director, Regulatory Affairs
Found in: Jooble US O C2 - 2 weeks ago
Waltham, MA, United States Alkermes Full timeThe Opportunity We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a...
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Manager, Regulatory Affairs
Found in: Resume Library US A2 - 1 week ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Description The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions. This...
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Manager/Sr. Manager, Regulatory Affairs
Found in: Appcast Linkedin GBL C2 - 3 weeks ago
Waltham, United States Planet Pharma Full timeJob Description:The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-functional development teams to assist in the development, communication, and execution of regulatory strategy and submission timelines.• Manage document and submission preparation and timelines for regulatory submissions to the FDA,...
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Manager/Sr. Manager, Regulatory Affairs
Found in: Appcast US C2 - 2 weeks ago
Waltham, United States Planet Pharma Full timeJob Description:The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-functional development teams to assist in the development, communication, and execution of regulatory strategy and submission timelines.• Manage document and submission preparation and timelines for regulatory submissions to the FDA,...
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Executive Director, Clinical Development
20 hours ago
Waltham, United States Alkermes Full timePosition Overview This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders. Key domains include development of study...
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Senior Director, GMP Quality Assurance, Commercial
Found in: Jooble US O C2 - 3 weeks ago
Waltham, MA, United States Taylor Strategy Partners Full timeDirector, GMP Quality Assurance, Commercial The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective actions, risk mitigation. They...
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Sr. Director, Clinical Regulatory Affairs
6 days ago
Waltham, United States Clincrowd Full timeMinimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required Experience supporting clinical development teams in the autoimmune disease space is a must Provides regulatory guidance and input to project teams Designs and implements regulatory strategies to obtain and maintain...
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Sr. Director, Clinical Regulatory Affairs
Found in: Appcast US C2 - 2 weeks ago
Waltham, United States ClinCrowd Full timeMinimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a mustProvides regulatory guidance and input to project teamsDesigns and implements regulatory strategies to obtain and maintain clinical...
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Sr. Director, Clinical Regulatory Affairs
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Waltham, United States ClinCrowd Full timeMinimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a mustProvides regulatory guidance and input to project teamsDesigns and implements regulatory strategies to obtain and maintain clinical...
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Sr. Director, Clinical Regulatory Affairs
2 weeks ago
Waltham, United States ClinCrowd Full timeMinimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a mustProvides regulatory guidance and input to project teamsDesigns and implements regulatory strategies to obtain and maintain clinical...
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Waltham, United States Taylor Strategy Partners Full timeDescription Sr. Director, GMP Quality Assurance, Commercial Position Summary: The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective...