Regulatory Affairs Director
4 days ago
We 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 Responsibilities- Manage the planning, preparation, and submission of regulatory dossiers in support of project goals, including developing and maintaining submission plans and timelines.
- Serve as the Regional Regulatory Lead (RRL) for assigned drug development programs.
- Lead cross-functional teams to deliver high-quality submissions, such as INDs, NDAs/BLAs, meeting requests, and briefing documents.
- Must possess at least six (6) years of relevant regulatory experience and eight (8) years of experience within the pharmaceutical or biotechnology industry.
- Strong analytical skills and problem-solving capabilities.
- Excellent communication skills (verbal and written) and ability to effectively communicate with Health Authorities and peer group members from diverse cultural backgrounds.
- Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace, remotely and in person.
- Ability to negotiate novel development and registration pathways for rare diseases.
The work environment is generally quiet, and the incumbent may occasionally attend meetings at ONO sites and relevant professional conferences. Travel could be scheduled based upon the needs of the business, up to 15% of the time, barring pandemic restrictions.
-
Regulatory Affairs Director
5 days 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...
-
Regulatory Affairs Director
1 week 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...
-
Regulatory Affairs Director
1 week 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....
-
Regulatory Affairs Director
2 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...
-
Director of Global Regulatory Affairs
6 days 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...
-
Director, Regulatory Affairs CMC
3 weeks ago
Cambridge, Massachusetts, United States Takeda Full timeRegulatory Affairs Director, Small MoleculesTakeda is seeking a highly experienced Regulatory Affairs Director, Small Molecules to lead our Global Regulatory Affairs CMC team. As a key member of our team, you will be responsible for overseeing the development and execution of regulatory CMC development and registration strategies.Key Responsibilities:Plan,...
-
Senior Director of Regulatory Affairs
2 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...
-
Director of Regulatory Affairs and Quality
1 week 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...
-
Senior Director of Regulatory Affairs
3 weeks ago
Cambridge, Massachusetts, United States Apnimed Full time{"title": "Senior Director of Regulatory Affairs", "content": "Job SummaryApnimed is seeking a highly experienced Senior Director of Regulatory Affairs to lead the development and execution of regulatory strategies to support the approval and commercialization of our therapies globally.This is a key role in advancing our innovative programs through clinical...
-
Senior Director of Global Regulatory Affairs
2 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...
-
Director of Regulatory Affairs and Quality
4 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob SummaryWe are seeking a highly experienced and skilled 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 ResponsibilitiesRegulatory Affairs Strategy and ExecutionDevelop and execute end-to-end regulatory...
-
Regulatory Affairs Director
5 days 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...
-
Director, Regulatory Affairs CMC
1 week 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...
-
Associate Director, Regulatory Affairs
1 week ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeJob Title: Associate Director, Regulatory Affairs - CMCAgios Pharmaceuticals is seeking a highly skilled Associate Director of Regulatory Affairs - CMC to join our team. As a key member of our Regulatory Affairs department, you will be responsible for leading CMC regulatory strategy to support global development and lifecycle management.Key...
-
Cambridge, Massachusetts, United States Apnimed Full timeAbout the RoleWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs and Compliance team at Apnimed. As a key member of our leadership team, you will play a critical role in advancing our innovative sleep apnea treatments through clinical trials and commercialization globally.Key ResponsibilitiesRegulatory Strategy and Planning:...
-
Cambridge, Massachusetts, United States Apnimed Full timeJob SummaryWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs and Compliance team at Apnimed. As a key member of our leadership team, you will be responsible for developing and executing regulatory strategies to support the approval and commercialization of our therapies globally.Key ResponsibilitiesRegulatory Strategy and...
-
Director, Global Regulatory Affairs
4 weeks ago
Cambridge, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory...
-
Senior Director, Regulatory Affairs
3 weeks ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeJob Summary:Proclinical Staffing is seeking a Senior Director, Regulatory Strategy to lead the development and execution of regulatory plans for programs within the assigned franchise. As an expert in regulatory affairs, you will be responsible for articulating clear and compelling regulatory strategy, highlighting risks and opportunities, and accounting for...
-
Senior Regulatory Affairs Specialist
1 week ago
Cambridge, Massachusetts, United States Takeda Full timeAbout the RoleAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device...
-
Regulatory Affairs Manager
4 days ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeJob Title: Manager, Regulatory Affairs LabelingProclinical Staffing is seeking a skilled Manager, Regulatory Affairs Labeling to join our team. As a key member of our Regulatory Affairs department, you will be responsible for leading the development of new labeling content and managing the creation and maintenance of all US product labeling components.Key...