Regulatory Affairs Director
5 days ago
At Ipsen Pharma, we are seeking a highly skilled and experienced Director, Regulatory Affairs, Rare Disease to join our team. This is a critical role that will be responsible for leading the development and implementation of regulatory strategies for our rare disease products.
Key Responsibilities:- Develop and execute regulatory strategies for rare disease products, ensuring compliance with global regulatory requirements.
- Provide regulatory expertise to R&D, Franchise, and Commercial Operations teams, ensuring alignment with business objectives.
- Build and maintain effective relationships with global regulators, ensuring timely and accurate information exchange.
- Lead operational excellence initiatives within the Global Regulatory Affairs (GRA) team, driving process improvements and efficiency.
- Contribute to the development of regulatory intelligence, monitoring scientific evolution and competitive regulatory information.
- Advanced degree in a scientific discipline (e.g., Pharmacy, Medicine, Chemistry, Biological Sciences).
- Minimum 10 years of experience in Regulatory Affairs, with a proven track record in drug development and managing complex worldwide products/projects.
- Fluent English language skills.
- Competitive annual base salary range: $177,000-$259,600.
- Eligibility to participate in our short-term and long-term incentives programs.
- A comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental, and vision coverage, life and disability insurance, and more.
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Regulatory Affairs Director
4 days ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeJob Title: Regulatory Affairs DirectorWe are seeking a highly skilled Regulatory Affairs Director to join our team at Proclinical Staffing. As a key member of our Commercial team, you will be responsible for providing regulatory leadership and guidance to ensure compliance with FDA regulations and industry guidelines.Key Responsibilities:Provide regulatory...
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Regulatory Affairs Director
3 weeks ago
Cambridge, Massachusetts, United States GlaxoSmithKline Full timeJob Title: Regulatory Affairs DirectorGlaxoSmithKline is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regional regulatory strategies to ensure compliance with internal GSK processes and regional regulatory requirements.Key...
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Regulatory Affairs Director
4 days ago
Cambridge, Massachusetts, United States PSG Global Solutions Careers Full timeAssociate Director Regulatory Affairs CMC Job DescriptionWe are seeking an experienced Associate Director Regulatory Affairs CMC to join our team at PSG Global Solutions Careers. As a key member of our regulatory affairs team, you will be responsible for developing and executing global regulatory CMC strategies for assigned programs.Key Responsibilities:Lead...
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Regulatory Affairs Director
5 days ago
Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full timeJob Title: Associate Director, Regulatory Affairs CMCVoyager Therapeutics, Inc. is seeking an experienced Associate Director to lead our Regulatory Affairs CMC team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing global Regulatory CMC strategies to secure approval of our gene therapy products.Key...
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Regulatory Affairs Director
3 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeJob Title: Director/Senior Director, Regulatory AffairsAbout the Role:Lifelancer is seeking a seasoned Regulatory Affairs professional to join our team as a Director/Senior Director, Regulatory Affairs. In this critical role, you will be responsible for developing and implementing global regulatory strategies for our development programs, ensuring compliance...
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Regulatory Affairs Director
3 weeks ago
Cambridge, Massachusetts, United States PSG Global Solutions Careers Full timeAssociate Director of Regulatory Affairs Job DescriptionAt PSG Global Solutions Careers, we're seeking a highly skilled Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market.Develop and...
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Regulatory Affairs Director
4 weeks ago
Cambridge, Massachusetts, United States ONO PHARMA USA Full time{"title": "Regulatory Affairs Director", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will be responsible for establishing and communicating regulatory strategies for development programs and coordinating the timelines, generation, and...
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Regulatory Affairs Director
3 weeks ago
Cambridge, Massachusetts, United States Lifelancer Full timeAbout the JobLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.Job DescriptionThe Director/Senior Director, Regulatory Affairs, is a regulatory leader with expert technical and tactical experience in regulatory strategy....
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Director of Global Regulatory Affairs
3 weeks ago
Cambridge, Massachusetts, United States GlaxoSmithKline Full timeJob Title: Director, Global Regulatory AffairsGlaxoSmithKline is seeking a highly skilled and experienced Director, Global Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and leadership on regulatory matters related to our RNA vaccines.Key...
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Regulatory Affairs Director
3 days ago
Cambridge, Massachusetts, United States Ipsen Pharma Full timeJob SummaryThe Director of Regulatory Affairs will be responsible for developing and implementing regulatory strategies for assigned programs and products. This includes providing regulatory expertise to R&D, Franchise, and Commercial Operations, as well as serving as the interface between these teams and the Global Regulatory Affairs (GRA) organization.Main...
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Director, PV Regulatory Affairs
2 weeks ago
Cambridge, Massachusetts, United States ONO PHARMA USA Full timeJob SummaryWe are seeking a highly experienced and skilled Director, PV Regulatory Affairs to join our team at ONO PHARMA USA. The successful candidate will be responsible for leading our Pharmacovigilance (PV) Regulatory Affairs function, ensuring compliance with regulatory requirements and developing strategies to enhance our PV capabilities.Key...
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Regulatory Affairs Director
2 weeks ago
Cambridge, Massachusetts, United States Lifelancer Full timeJob Title: Director/Senior Director, Regulatory AffairsAbout the Role:Cullinan Therapeutics, Inc. is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in...
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Senior Director of Regulatory Affairs
4 weeks ago
Cambridge, Massachusetts, United States Apnimed Full timeJob Title: Senior Director, Regulatory AffairsApnimed is a clinical-stage pharmaceutical company dedicated to transforming the treatment of sleep apnea. We are seeking a highly experienced Senior Director of Regulatory Affairs to play a key role in advancing our innovative programs through clinical trials and commercialization globally.Key...
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Director of Regulatory Affairs and Quality
3 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob SummaryWe are seeking a highly experienced Director of Regulatory Affairs and Quality to lead our Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities.Key ResponsibilitiesLead the development and execution of regulatory and quality strategies to maintain current...
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Senior Director of Global Regulatory Affairs
4 weeks ago
Cambridge, Massachusetts, United States Takeda Full timeSenior Director of Global Regulatory AffairsTakeda is seeking a highly experienced Senior Director of Global Regulatory Affairs to lead our team in developing and implementing global regulatory strategies for pharmaceutical products. As a key member of our organization, you will play a critical role in ensuring successful regulatory submissions and...
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Cambridge, Massachusetts, United States ONO PHARMA USA Full timeJob SummaryWe are seeking a highly experienced Director of Pharmacovigilance Regulatory Affairs to lead our PV Regulatory Affairs function. The successful candidate will be responsible for developing and implementing PV strategies, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive business growth.Key...
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Regulatory Affairs Director
3 weeks ago
Cambridge, Massachusetts, United States ONO PHARMA USA Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will serve as a Health Authority liaison and establish and communicate regulatory strategies for development programs.Key ResponsibilitiesManage the planning, preparation, and submission of regulatory dossiers...
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Regulatory Affairs Director
3 weeks ago
Cambridge, Massachusetts, United States ONO PHARMA USA Full timeJob SummaryWe are seeking an experienced Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will establish and communicate regulatory strategies for development programs and coordinate the timelines, generation, and submission of complex regulatory dossiers.Key ResponsibilitiesManage the planning,...
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Global Regulatory Affairs Director
4 days ago
Cambridge, Massachusetts, United States Takeda Development Center Americas, Inc Full timeJob Opportunity at Takeda Development Center Americas, Inc.We are seeking a highly skilled Associate Director, Global Regulatory Affairs to join our team in Cambridge, MA. As a key member of our regulatory team, you will be responsible for overseeing and executing all regulatory activities for multiple projects, including a complex project in development....
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Director, Regulatory Affairs CMC
4 weeks ago
Cambridge, Massachusetts, United States Takeda Full timeDirector, GRA CMC Small MoleculesTakeda is seeking a highly skilled Director, GRA CMC Small Molecules to lead the development and execution of regulatory CMC development and registration strategies. As a key member of the Global Regulatory Affairs CMC team, you will oversee the development and execution of regulatory CMC development and registration...