Regulatory Strategist/Project Manager
2 months ago
Title: Regulatory Strategist / Project Manager (Biologics)
Location: Waltham, MA
Job Type: Contract-to-Hire
Onsite vs. Remote: Hybrid (2-3 Days Onsite)
Start Date: ASAP
Looking for a Regulatory Strategist with BLA experience for a world-renowned CRO on a contract-to-hire basis
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Regulatory Operations Director
1 week ago
Waltham, Massachusetts, United States Syndax Pharmaceuticals Full timeAbout the Role:Syndax Pharmaceuticals is seeking an Executive Director, Regulatory Operations to formulate and implement a regulatory operations vision and strategy for a commercial stage biotechnology company.The ideal candidate will be responsible for envisioning and implementing a fit-for-purpose Regulatory Information Management (RIM) system across...
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Regulatory Affairs Director
1 month ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Affairs CMC is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...
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Regulatory Affairs Project Manager
1 week ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeRegulatory Affairs Project ManagerAbout the Role:We are seeking an experienced Regulatory Affairs Project Manager to join our team at BioSpace, Inc. The successful candidate will work closely with the Global Regulatory Affairs, Regulatory Operations, and cross-functional teams to facilitate timely submission of high-quality data packages to US and...
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Regulatory Affairs Project Manager
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob SummaryThe Regulatory Affairs Project Manager is a key member of the Global Regulatory Affairs team, responsible for facilitating timely submission of high-quality data packages to US and international health authorities. This role provides support to cross-functional teams, tracks and coordinates deliverables for regulatory timelines, and develops...
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Regulatory Affairs Project Manager
2 weeks ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Regulatory Affairs Project ManagerAt Dyne Therapeutics, we are seeking a highly experienced Regulatory Affairs Project Manager to join our team. As a key member of our Global Regulatory Affairs team, you will play a critical role in facilitating timely submission of high-quality data packages to US and international health authorities.Key...
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Regulatory Affairs Project Manager
1 week ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Regulatory Affairs Project ManagerThe Regulatory Affairs Project Manager is a key member of the Global Regulatory Affairs team at BioSpace, Inc. This role is responsible for facilitating timely submission of high-quality data packages to US and international health authorities. The successful candidate will work closely with cross-functional teams...
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Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob Title: Associate Director, Regulatory CMCThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key Responsibilities:Lead CMC regulatory execution for...
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Global Regulatory Lead
1 week ago
Waltham, Massachusetts, United States AbbVie Full timeJob DescriptionAbbVie's MissionAbbVie is committed to discovering and delivering innovative medicines and solutions that address serious health issues today and tomorrow.We strive to have a remarkable impact on people's lives across key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...
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Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob Title: Associate Director, Regulatory CMCThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) plays a pivotal role in executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne's clinical registration, commercial development, and...
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Global Regulatory Lead Director
1 week ago
Waltham, Massachusetts, United States AbbVie Full timeJob Description:The Director of Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in assigned therapeutic areas.Key Responsibilities:Leads the Global Regulatory Product Team (GRPT) to develop creative global strategies in line with applicable regulations to achieve...
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Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director, Regulatory Chemistry Manufacturing and ControlThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics Inc, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key...
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Associate Director, Regulatory CMC
1 month ago
Waltham, United States Dyne Therapeutics Full timeThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne’s clinical registration, commercial development, and manufacturing efforts, as applicable. This position...
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Associate Director, Regulatory CMC
1 month ago
Waltham, United States Dyne Therapeutics Full timeThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne’s clinical registration, commercial development, and manufacturing efforts, as applicable. This position...
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Associate Director Regulatory Affairs CMC
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director, Regulatory Affairs CMCDyne Therapeutics Inc is seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. As a key member of our Regulatory Affairs department, you will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond...
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Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director, Regulatory Chemistry Manufacturing and ControlThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics Inc, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key...
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Associate Director Regulatory Affairs CMC
2 weeks ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Associate Director, Regulatory Affairs CMCJob Summary:Dyne Therapeutics is seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. The successful candidate will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key...
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Associate Director Regulatory Affairs CMC
3 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryDyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are seeking an experienced Associate Director, Regulatory Affairs CMC to join our team.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all...
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Regulatory Affairs Manager
2 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob SummaryDeciphera Pharmaceuticals is seeking a highly skilled Manager/Senior Manager, Regulatory CMC to join our Post-Approval Group within the Regulatory Affairs Organization. This role will lead, contribute, and execute on post-approval CMC regulatory activities in support of our globally approved marketing applications.The ideal candidate will have 6+...
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Associate Director Regulatory Affairs CMC
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob Title: Associate Director, Regulatory Affairs CMCCompany 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...
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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...