Sr. Director, Clinical Regulatory Affairs
3 weeks ago
- Minimum 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 clinical trial applications
- Oversees the creation and submission of all regulatory filings
- Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
- Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals
- Experience in Oncology and Immuno-oncology is preferred but not required
- Arranges for and leads meetings with global health authorities as needed
- Provides training and mentorship to regulatory staff and other junior staff at the company
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Senior Director, Clinical Regulatory Affairs
2 weeks ago
Waltham, United States Dragonfly Therapeutics, Inc. 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, Clinical Regulatory Affairs
2 weeks 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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Director, CMC Regulatory Affairs
4 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, Regulatory Affairs
3 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...
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Director of Regulatory Affairs
4 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, Regulatory Affairs
3 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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Sr. Director, Clinical Regulatory Affairs
4 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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Director, CMC Regulatory Affairs
4 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, Regulatory Affairs
3 weeks 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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Executive Director, Medical Affairs
2 days ago
Waltham, United States Morphic Therapeutic Full timeAbout Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrdinger, Morphic is advancing its pipeline and discovery activities using...
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Associate Director Clinical Operations
17 hours ago
Waltham, United States Meet Full timeTitle: Associate Director, Clinical Operations - Rare Disease/Oncology Background NeededLocation: Waltham, MA (Onsite 2 Days Weekly)Key Responsibilities:Lead and oversee the execution of clinical trials within the rare disease and oncology therapeutic areas.Develop and implement strategic plans for clinical trial operations to ensure timely and successful...
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Associate Director Clinical Operations
5 days ago
Waltham, United States Meet Full timeTitle: Associate Director, Clinical Operations - Rare Disease/Oncology Background NeededLocation: Waltham, MA (Onsite 2 Days Weekly)Key Responsibilities:Lead and oversee the execution of clinical trials within the rare disease and oncology therapeutic areas.Develop and implement strategic plans for clinical trial operations to ensure timely and successful...
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Manager/Senior Manager, CMC Regulatory Affairs
3 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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Regulatory Manager
3 weeks ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...
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Regulatory Manager
3 weeks ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...
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Regulatory Manager
4 weeks ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...
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Associate Director, Clinical Scientist
4 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...
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Waltham, United States GlaxoSmithKline Full timeSite Name: USA - North Carolina - Research Triangle Park, Bangalore, India - Maharashtra - Mumbai, Poznan Grunwaldzka, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: May 9 2024 Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of...
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Associate Director, Clinical Scientist
2 weeks ago
Waltham, United States BioSpace Full timeJob DetailsCompany 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...
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Associate Director, Clinical Scientist
3 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....