Regulatory Submission Management Director

Job DescriptionAt Takeda Pharmaceutical, we are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status,...

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,...

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...

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 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...

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...

About the Role:Takeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are seeking a highly skilled Manager, Global Regulatory Affairs CMC Submission Management to support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned...

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...

About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.We are seeking a highly experienced Director, Regulatory Affairs CMC Small Molecules to oversee the development and execution of regulatory CMC development and registration...

About the RoleTakeda is seeking an Associate Director, Global Regulatory Lead, GI and Inflammation to join our team. As a key member of our R&D organization, you will be responsible for defining, developing, and leading global strategies to maximize regulatory success for complex and/or multiple projects.Key ResponsibilitiesProvide strategic and tactical...

Job Title: CMC Submissions LeadTakeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in Cambridge, MA.Key Responsibilities:Develop and maintain regulatory submission content plans, timelines, and submission strategies.Establish submission structures in electronic common technical document format for CMC Module 3...

About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are seeking a Senior Director, Global Regulatory Lead, GI to join our team.This role will be responsible for defining, developing, and leading global strategies to...

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...

About the Role:Takeda is seeking a highly skilled Associate Director, Global Regulatory Lead, GI & Inflammation to join our team. As a key member of our regulatory affairs department, you will be responsible for defining, developing, and leading global strategies to maximize regulatory success for complex and/or multiple projects.You will provide strategic...

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...

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...

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...

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,...

Job Summary:We are seeking a highly skilled and experienced Director of Regulatory Compliance to join our team at Fidelity Investments. As a key member of our Compliance department, you will be responsible for ensuring that our digital asset services comply with all relevant regulatory requirements.Key Responsibilities:Lead the development and implementation...