Regulatory Affairs Manager
1 week ago
We are seeking a highly skilled Regulatory Affairs Manager to join our team at GSK. As a key member of our global regulatory affairs team, you will be responsible for developing and implementing regional regulatory strategies to support the development and launch of our products.
Key Responsibilities- Develop and implement regional regulatory strategies to support product development and launch
- Lead regulatory interactions with local and regional authorities
- Collaborate with cross-functional teams to ensure compliance with global and regional regulatory requirements
- Provide regulatory expertise and guidance to support business decisions
- Stay up-to-date with changing regulatory landscapes and ensure compliance with all relevant regulations
- Bachelor's degree in Biological or Healthcare Science
- Experience in regulatory affairs, preferably in a pharmaceutical industry
- Strong knowledge of regulatory requirements in major countries and regions
- Excellent communication and interpersonal skills
- Ability to work in a matrix environment and collaborate with cross-functional teams
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application.
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Head of Regulatory Affairs
2 weeks ago
Waltham, Massachusetts, United States Mural Oncology Full timeJob Title: Head of Regulatory AffairsMural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer.We are seeking a highly experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and ensure compliance with global regulatory...
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Regulatory Affairs Director
2 weeks ago
Waltham, Massachusetts, United States Weber & Company Full timeExecutive Director Regulatory AffairsJob Summary:Weber & Company is seeking an experienced Executive Director Regulatory Affairs to lead our client's regulatory affairs team in Greater Boston. As a key member of the leadership team, you will be responsible for developing and implementing a regulatory strategy that accelerates product approvals and maintains...
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Regulatory Affairs Director
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Waltham, Massachusetts, United States Taylor Strategy Partners Full timeJob Title: Director, Regulatory Affairs Job Summary: We are seeking a highly experienced Director, Regulatory Affairs to lead our regulatory strategy and operations. As a key member of our team, you will be responsible for developing and implementing a consolidated regulatory strategy to secure and maintain market access for our products. Key...
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Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Ventus Therapeutics Full timeAbout Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop innovative small molecule medicines for challenging targets. Our initial focus areas include immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and...
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Regulatory Affairs Director
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Waltham, Massachusetts, United States Innoviva Specialty Therapeutics Full timeJob Title: Vice President, Head of Regulatory AffairsAt Innoviva Specialty Therapeutics, we are seeking a highly experienced and skilled Vice President, Head of Regulatory Affairs to lead our regulatory strategy and ensure compliance with global regulatory requirements.Job Summary:The successful candidate will be responsible for developing and executing...
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Regulatory Affairs Director
3 weeks 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 Director
4 weeks ago
Waltham, Massachusetts, United States Meet Full timeRegulatory Affairs Leadership OpportunityWe are seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic direction in this critical role.Key Responsibilities:Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departmentsDrive planning and implementation of meetings...
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Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Meet Full timeRegulatory Affairs Leadership OpportunityWe are seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic direction in this critical role.Key Responsibilities:Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departmentsDrive planning and implementation of meetings...
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Regulatory Affairs Director
1 week 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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Regulatory Affairs Director
1 week 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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Regulatory Affairs Director
2 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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Regulatory Affairs Director
1 month ago
Waltham, Massachusetts, United States Muraloncology Full timeAbout the RoleMuraloncology is seeking a highly skilled and experienced Regulatory Affairs Director to lead our Regulatory Strategy team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to support the approval and commercialization of our oncology products.Key...
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Regulatory Affairs Director
3 weeks ago
Waltham, Massachusetts, United States Trebla Talent Full timeJob Title: Executive Director, Regulatory AffairsCompany: Trebla TalentLocation: Massachusetts - HybridJob Type: Full-timeAbout the Company:Trebla Talent is a leading recruitment agency specializing in placing top talent in the biotech and pharmaceutical industries.Job Description:We are seeking an experienced Executive Director to lead our Regulatory...
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Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Trebla Talent Full timeRole:We are seeking a seasoned Regulatory Affairs expert to lead our team and drive strategic decisions across our portfolio.Company Overview:Trebla Talent is proud to partner with a pre-IPO, clinical-stage biotech company that is revolutionizing cancer and autoimmune treatments through innovative immunotherapies.Key Responsibilities:As the Executive...
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Regulatory Affairs Operations Manager
6 days ago
Waltham, Massachusetts, United States Fresenius Medical Care Holdings, Inc. Full timeJob Title: Regulatory Affairs Operations ManagerJob Summary:Fresenius Medical Care North America is seeking a highly skilled Regulatory Affairs Operations Manager to oversee all regulatory activities for new and mature products. The successful candidate will ensure alignment and compliance with local and regional requirements, as well as company policies.Key...
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Head of Clinical Regulatory Affairs
2 weeks ago
Waltham, Massachusetts, United States Dragonfly Therapeutics, Inc. Full timeJob Title: Head of Clinical Regulatory AffairsDragonfly Therapeutics, Inc. is seeking a highly skilled and experienced Head of Clinical Regulatory Affairs to lead our Regulatory Affairs organization. As a key member of our team, you will be responsible for developing and implementing comprehensive regulatory strategies for biologics in early Phase clinical...
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Vice President of Regulatory Affairs
2 weeks ago
Waltham, Massachusetts, United States Taylor Strategy Partners Full timeJob DescriptionCompany OverviewTaylor Strategy Partners is a biopharmaceutical company dedicated to developing and delivering innovative therapies in critical care and infectious disease. Our approved treatments address high unmet medical needs for serious conditions, and our investigational therapies are in development for patients fighting drug-resistant...
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Senior Director, Head of Regulatory Affairs
1 month ago
Waltham, Massachusetts, United States Ventus Therapeutics Full timeAbout Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and develop...
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Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) will be 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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Senior Vice President, Regulatory Affairs Lead
2 weeks ago
Waltham, Massachusetts, United States Meet Full timeRegulatory Affairs Leadership OpportunityVice President/Senior Vice President, Regulatory Affairs*Based in New England or flexible to travel*Key Responsibilities:Provide strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departments, leading the Regulatory Affairs group in hiring, mentoring, and staff management.Drive the...