Regulatory Affairs Specialist

Job Title: Paralegal Specialist for Regulatory AffairsJob Summary:We are seeking a skilled Paralegal Specialist to join our team at Dexian DISYS. As a Paralegal Specialist for Regulatory Affairs, you will be responsible for providing administrative support to our regulatory team.Key Responsibilities:Complete data entry onto excel spreadsheets, sort data, and...

Job DescriptionThe 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 critical regulatory guidance to internal development teams and prepares comprehensive...

Job SummaryThe Senior Specialist, Regulatory Affairs will play a key role in supporting the regulatory submissions process through the development of regulatory strategy and submission of materials to health authorities such as the FDA for approval of novel platforms. This position will provide regulatory guidance to internal development teams and prepare...

Regulatory Affairs Specialist RolePathAI is seeking an experienced Regulatory Affairs Specialist to support the development and approval of our diagnostic products. As a key member of our regulatory team, you will work closely with cross-functional teams to ensure compliance with regulatory requirements and guidelines.Key Responsibilities:Prepare and manage...

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...

Senior Director, Regulatory Affairs **Job Summary:** Proclinical is seeking a dynamic and strategic leader for the role of Senior Director of Regulatory Affairs. This position is pivotal in driving regulatory efforts for vaccine development programs. **Primary Responsibilities:** * Manage the full lifecycle of global regulatory submissions and approvals,...

Regulatory Affairs ProfessionalMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to support the global development and approval of our innovative therapies.This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing...

About the Role:Takeda Pharmaceutical is seeking a highly skilled Regulatory Affairs Manager to support the execution of regulatory CMC investigational, registration, and post-approval tasks for assigned products. As a key member of the Regulatory Affairs CMC team, you will work closely with cross-functional teams to develop project plans for global...

Job Summary:Fairway Consulting Group is seeking a highly experienced Regulatory Affairs Director to lead our client's global regulatory strategy and execution on development programs. The ideal candidate will have a comprehensive knowledge of the drug development process, global regulations and guidelines, and a comprehensive understanding of global...

Regulatory Affairs Senior Manager**Job Summary:**Monte 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...

About the RoleWe are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team at Xenon Inc. This role will be responsible for developing and implementing global regulatory strategies to support the advancement of our product pipeline.ResponsibilitiesProvide regulatory support on multidisciplinary project/clinical study teams, including...

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 DescriptionThe Head of Regulatory Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a best-in-class Regulatory Operations organization. The role will involve envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the...

Job SummaryThe Senior Director, Regulatory Strategy, is a key member of the Vertex Pharmaceuticals team responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs. This role plays a major role in shaping cohesive regulatory strategy across assigned programs and ensuring effective...

We are seeking a highly skilled GCP Quality Assurance Specialist to join our team at Gardner Resources Consulting. The ideal candidate will have a strong background in regulatory compliance and quality assurance, with experience in the pharmaceutical or biotechnology industry.The GCP Quality Assurance Specialist will provide strategic leadership and...

Beacon Hill Life Sciences - Boston is seeking a skilled Regulatory Operations Specialist to join their team. This role will focus on ECTD productions, document publishing, and document management. As a Regulatory Operations Specialist, you will be responsible for representing the company by participating on assigned teams to support submission scheduling and...

Job Summary:The Director, Regulatory CMC, Biologics will lead a team in the execution of global regulatory CMC strategies for investigational and marketed biologics products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing interactions with Health Authorities for CMC topics.Key Responsibilities:Oversee the...

Job Title: Associate Director, Regulatory Submission ManagementAbout the Role:We are seeking an experienced Associate Director to lead our Regulatory Submission Management team. As a key member of our Global Regulatory Affairs team, you will be responsible for planning, managing, and tracking regulatory submissions across multiple programs.Key...

About Northern Trust:Northern Trust is a globally recognized financial institution with a rich history dating back to 1889. We provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by upholding our core values of service, expertise, and integrity.With over 130 years of financial experience...

Job SummaryBeacon Hill Life Sciences - Boston is seeking a highly skilled Regulatory Operations Contractor to support the development and implementation of systems and procedures used to support regulatory submission activities.This role will involve assisting with the production of electronic regulatory submissions, coordinating with cross-functional teams,...