Senior Director of Regulatory Affairs

Senior Director, Regulatory Affairs **Job Summary:** Proclinical is seeking a seasoned regulatory professional to lead our vaccine development programs. As Senior Director, Regulatory Affairs, you will be responsible for driving regulatory efforts and ensuring compliance across major markets. **Key Responsibilities:** * Develop and execute regulatory...

Job Title: Director, Regulatory AffairsWe are seeking a highly experienced Director, Regulatory Affairs to join our team at Fairway Consulting Group. As a key member of our team, you will be responsible for providing strategic regulatory leadership and guidance to project teams, ensuring clinical trials are designed to meet regulatory requirements, and...

Join Our Team as a Senior Manager Regulatory AffairsSpencer Rigby is a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes.We are seeking a highly skilled Senior Manager Regulatory Affairs Specialist to play a pivotal role in...

Job Title: Associate Director, Global Regulatory AffairsAt Takeda Pharmaceutical, we are seeking an experienced Associate Director, Global Regulatory Affairs to join our team in Cambridge, MA.Job Summary:We are looking for a highly skilled and motivated individual to lead our global regulatory strategy and ensure compliance with regulatory requirements. The...

Join Our Team as a Senior Manager Regulatory AffairsSpencer Rigby is a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes.We are seeking a highly skilled Senior Manager Regulatory Affairs Specialist to play a pivotal role in...

Senior Manager, Regulatory AffairsMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team. This role will focus on oncology, immunology, and related therapeutic areas.Key Responsibilities:Develop and implement regulatory strategies to support the global development and approval of our innovative...

Takeda Pharmaceutical Job OpportunityWe are seeking an experienced professional to join our team as an Associate Director, Global Regulatory Affairs. This role will be based in Cambridge, MA and will involve working on late-stage development projects in multiple indications, device platforms, and cell line changes.Key Responsibilities:Provide global...

Senior Specialist, Regulatory AffairsThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process at Foundation Medicine. This involves developing and implementing regulatory strategies to ensure compliance with health authority regulations, such as those set by the FDA. The successful candidate will be...

Regulatory Affairs SpecialistThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process at Foundation Medicine. This involves developing regulatory strategies and submitting materials to health authorities such as the FDA for approval of novel platforms.Key Responsibilities:Develop and implement...

About the JobThe Senior Specialist, Regulatory Affairs plays a pivotal role in supporting the regulatory submissions process by developing strategic plans and submitting materials to health authorities such as the FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document packages for...

Job Title: Regulatory Affairs SpecialistAt Katalyst Healthcares and Life Sciences, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the compliance of our medical devices with global regulatory requirements.Responsibilities:Develop and implement...

Regulatory Affairs SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing regulatory guidance to cross-functional partners and developing global regulatory strategies for new and modified medical devices.Key...

About the RoleThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process by developing regulatory strategies and submitting materials to health authorities such as the FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document...

About the RoleThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process by developing regulatory strategies and submitting materials to health authorities such as the FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document...

Regulatory Affairs SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Provide regulatory guidance to cross-functional partners and develop global regulatory strategies for new and modified medical devices.Assist in the development of regulatory strategies for new...

Job SummaryThe Chemistry Manufacturing Controls Associate Director at Vertex is responsible for executing global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. The Associate Director provides...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Katalyst Healthcares and Life Sciences. The successful candidate will be responsible for interpreting regulatory filings and leading cross-functional teams to ensure compliance with new or revised regulations.Key ResponsibilitiesInterpret regulatory filings and lead...

About the JobThe Regulatory Affairs Manager is responsible for supporting the regulatory function and its activities, developing regulatory strategy, and contributing to the regulatory approval process for FMI products. FMI's products include diagnostic assays that provide molecular insights to physicians to guide treatment options for cancer patients.Key...

Regulatory Affairs Coordinator Job SummaryWe are seeking a highly organized and detail-oriented Regulatory Affairs Coordinator to join our team at Mass General Brigham. The successful candidate will work closely with investigators, sponsors, and research support staff to ensure regulatory requirements are met for clinical trials.Key Responsibilities:Prepare...

Regulatory Affairs Coordinator Job DescriptionWe are seeking a highly organized and detail-oriented Regulatory Affairs Coordinator to join our team at Mass General Brigham. The successful candidate will work closely with investigators, sponsors, and research support staff to ensure regulatory requirements are met for clinical trials.Key...