Senior Manager, US Medical Ad/Promo Regulatory Review
2 weeks ago
Takeda is seeking a highly skilled Senior Manager, US Medical Ad/Promo Regulatory Review to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with FDA regulations and guidelines for the promotion of prescription drug and biologic products.
Key Responsibilities- Collaborate with cross-functional teams to develop and implement regulatory strategies for promotional materials
- Review and assess proposed promotional items to ensure compliance with regulatory requirements
- Provide regulatory guidance and support to commercial teams
- Develop and maintain relationships with regulatory agencies and industry partners
- Stay up-to-date with changes in regulatory requirements and guidelines
- Bachelor's degree in life science or equivalent
- Minimum 4 years' experience in drug, biologic or device Regulatory Affairs or related field
- Strong knowledge of FDA regulations and guidelines
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced environment
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
- Recognition and rewards for outstanding performance
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Lexington, Massachusetts, United States Takeda Full timeAbout the RoleWe are seeking a highly skilled Senior Manager, US Medical Ad/Promo Regulatory Review to join our team at Takeda. As an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products, you will provide regulatory strategic oversight for at least one complex product or...
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Senior Director Regulatory Affairs Strategy
1 week ago
Lexington, Massachusetts, United States Kiniksa Pharmaceuticals Full timeJob Title: Senior Director, Regulatory Affairs StrategyAt Kiniksa Pharmaceuticals, we are seeking a highly experienced Senior Director to lead our Regulatory Affairs Strategy team. As a key member of our organization, you will be responsible for developing and implementing global regulatory strategies to ensure the successful registration and life-cycle...
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Regulatory Affairs Manager
2 weeks ago
Lexington, Massachusetts, United States Takeda Development Center Americas, Inc Full timeJob Title: Manager, Global Regulatory Affairs CMC Submissions ManagementTakeda Development Center Americas, Inc. is seeking a highly skilled professional to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, and Biologics.Key Responsibilities:Develop and implement...
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Regulatory Affairs Manager
1 week ago
Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeJob SummaryTakeda Development Center Americas, Inc. is seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global CMC regulations for advanced therapies and biological compounds.Key...
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Regulatory Affairs Manager
3 weeks ago
Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeJob SummaryTakeda Development Center Americas, Inc. is seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global CMC regulations for advanced therapies and biological compounds.Key...
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Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the Role:Takeda Pharmaceutical is seeking a highly skilled Senior Regulatory Affairs Director to lead the development and execution of global CMC regulatory strategies for assigned products. As a key member of the Global Regulatory Affairs CMC team, you will be responsible for ensuring regulatory compliance with global health authorities and developing...
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Regulatory Affairs Manager
3 weeks ago
Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeAt Takeda Pharmaceutical, we are seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA.Key Responsibilities:Develop and maintain strong working relationships with the regulatory CMC team and cross-functional teams.Participate on and/or lead multifunctional teams to handle and prioritize...
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Regulatory Affairs Manager
5 days ago
Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda Development Center Americas, Inc.is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements:Key Responsibilities:Develop and maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams,...
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Lexington, Massachusetts, United States Kiniksa Pharmaceuticals Full timeJob SummaryKiniksa Pharmaceuticals is a commercial stage, publicly traded biopharmaceutical company with a mission to help patients suffering from debilitating diseases with significant unmet medical need. We are seeking a highly skilled Senior Manager, Upstream Process Development and Manufacture to join our team.Key ResponsibilitiesManage and support tech...
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Senior Engineering Manager
1 week ago
Lexington, Massachusetts, United States Johnson and Johnson Full timeSenior Engineering Manager Job DescriptionJohnson and Johnson is seeking a highly skilled Senior Engineering Manager to join our team. As a key member of our CMC team, you will be responsible for representing the device function on development programs and working closely with Quality, Regulatory, Commercial, and other stakeholders to ensure the successful...
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Lexington, Massachusetts, United States Kiniksa Pharmaceuticals Full timeJob SummaryKiniksa Pharmaceuticals is seeking a highly skilled and experienced Director/Senior Director, Program and Alliance Management to lead and champion global program teams and applicable subteams for advancing Kiniksa's product candidates within our growing development portfolio.Key ResponsibilitiesEstablish, lead, and champion global program teams...
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Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeJob SummaryWe are seeking an experienced Associate Director to lead our Analytical Development team in Bioanalytics Late Stage. The successful candidate will have a strong background in analytical development, with expertise in scientific methods and technology implementation. They will be responsible for driving team objectives, managing team performance,...
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QC Manager
2 weeks ago
Lexington, Massachusetts, United States Genezen Full timeJob Title: Quality Control ManagerWe are seeking a highly skilled Quality Control Manager to join our team at Genezen. As a Quality Control Manager, you will be responsible for overseeing the day-to-day operations of the QC Bioassay and Virology Testing group within the QC Operations department.Key Responsibilities:Maintain a safe, efficient, functional, and...
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Lexington, Massachusetts, United States Genezen Full timeJob Title: Senior Quality Assurance Specialist, Laboratory OperationsJob SummaryThe Senior Quality Assurance Specialist – Laboratory Operations plays a critical role in ensuring the quality and integrity of Genezen's biologics manufacturing processes. This position is responsible for overseeing the day-to-day quality operations, including deviations,...
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Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda is seeking a highly skilled Senior Scientist to join our Analytical Development team in Biologics Early Stage. As a key member of our team, you will be responsible for leading efforts in the development of scientific methods, implementing evolving scientific technology, and influencing strategic planning within AD and across...
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Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda is seeking a highly skilled Senior Scientist to lead efforts in the development of scientific methods and implementation of evolving scientific technology in our Analytical Development Biologics Early Stage team.As a key member of our team, you will independently design and execute experimental plans, define complex or novel resolutions...
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Senior Optical Engineer, Imaging
2 weeks ago
Lexington, Massachusetts, United States Anduril Industries Full timeJob Title: Senior Optical Engineer, ImagingAnduril Industries is a defense technology company that is revolutionizing the way military systems are designed, built, and sold. We are seeking a highly skilled Senior Optical Engineer to join our team and contribute to the development of cutting-edge imaging systems for tactical airborne applications.Key...
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Senior Reliability Engineer
4 weeks ago
Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the Role:We are seeking a highly skilled Senior Reliability Engineer to join our team at Takeda Pharmaceutical. As a key member of our Reliability Engineering group, you will play a critical role in improving the reliability of our equipment, utilities, and critical systems.As a Senior Reliability Engineer, you will lead reliability-driven actions that...
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Senior Clinical Research Coordinator
1 week ago
Lexington, Massachusetts, United States Massachusetts General Hospital Full timeJob SummaryThe Senior Clinical Research Coordinator will oversee a portfolio of clinical research projects in the Lurie Center for Autism Division, working independently with minimal guidance from the PI. This role is responsible for leading the development, implementation, and analysis of clinical research projects, ensuring adherence to quality, safety,...
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Senior Manager, Statistical Programming Lead
1 week ago
Lexington, Massachusetts, United States Takeda Development Center Americas, Inc Full timeJob Title: Senior Manager, Statistical ProgrammingTakeda Development Center Americas, Inc. is seeking a highly skilled Senior Manager, Statistical Programming to lead projects directly or indirectly related to GPTs or other functions. This is a full-time position with a salary range of $224,000 - $258,000 per year.Key Responsibilities:Lead projects related...