Regulatory Affairs Director

**Job Description:**We are seeking an experienced Regulatory Affairs Director to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's global regulatory strategy.**Responsibilities:Develop and implement global regulatory strategies to maximize regulatory success...

Job Title: Regulatory Affairs Director - AmericasAbout the Role:Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from...

About Our CompanyWe are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Our teams are united by an unwavering commitment to deliver better health and a brighter future to people around the world.Job SummaryThe Associate Director, Global Labeling Lead will oversee the development...

Medical Device Regulatory Expert WantedWe are seeking a seasoned Regulatory Affairs Manager to join our team in Boston, MA. This role is crucial for ensuring our medical devices meet all regulatory requirements and standards.About the RoleThis is an exciting opportunity for a hands-on professional with a strong background in medical devices, particularly...

Senior Regulatory Professional for Innovative TherapiesMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas.The successful candidate will be responsible for developing and...

About the RoleWe are seeking an experienced Director of Global Regulatory Strategy to lead our regulatory affairs efforts and establish a global strategy for multiple BLA programs.Company OverviewTrebla Talent is a pre-IPO, clinical-stage biotech company specializing in novel immunotherapies for cancer and autoimmune diseases. Our team is dedicated to...

Job OverviewThe role of Senior Regulatory Affairs Expert, Labeling Compliance Specialist at Takeda Pharmaceutical is a pivotal position that ensures the company's products meet regulatory requirements and maintain compliance with global labeling standards.This position plays a crucial role in ensuring Takeda gains regulatory approval for new products and...

Job DescriptionMeet our team and explore the opportunity to support the regulatory process as a Regulatory Affairs Compliance Specialist.We are seeking an experienced professional to manage KPIs, generate reports, and collaborate cross-functionally to ensure compliance with global regulatory requirements.Responsibilities:Collaborate with regulatory teams...

Position OverviewWe are seeking a highly experienced Regulatory Affairs Strategist to drive regulatory strategy for our anti-infective portfolio through all development phases.This role involves co-leading a US NDA with a cross-functional project team and serving as the primary liaison with the FDA. The ideal candidate will have strong communication,...

Transformative Leadership OpportunityTakeda Pharmaceutical is seeking an exceptional Global Regulatory Affairs Transformation Leader to spearhead the development of a best-in-class Regulatory Operations organization.The successful candidate will be responsible for envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the...

Develop a Strategic State Government Affairs StrategyAs a seasoned State Government Affairs Director at Vertex Pharmaceuticals, you will play a pivotal role in developing and implementing the company's state/regional government affairs and public policy strategy. This critical position will work closely with various functional areas to lead the company's...

This role will be responsible for ensuring adherence to global compliance standards and FDA regulations in the creation, review, and approval of advertising and promotional materials.As a Director, Advertising and Promotion Compliance, you will serve as the Regulatory Affairs representative for assigned products and therapeutic areas. You will engage...

Job OverviewCoverys is a leading insurance company providing innovative solutions to customers across the United States. We are seeking an experienced Regulatory Counsel to join our team, responsible for ensuring compliance with regulatory requirements and providing expert advice on complex insurance matters.

Job SummaryVertex Pharmaceuticals Incorporated is seeking a highly skilled State Government Affairs Director to join our team. As a field-based position, this role will be responsible for developing and implementing the company's state/regional government affairs and public policy strategy.About the RoleThis is a critical position that will work closely with...

Senior Regulatory Affairs Leadership OpportunityWe are seeking a highly experienced and visionary leader to head our Global Regulatory Operations team at Takeda Pharmaceutical. As a key member of our senior leadership team, you will be responsible for driving the development and implementation of our regulatory strategy, ensuring compliance with global...

**Job Summary:** We are seeking an experienced Lead Regulatory Expert to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's global regulatory strategy.**Responsibilities:Develop and implement global regulatory strategies to maximize regulatory success for...

Planet Pharma is seeking an experienced Associate Director of Regulatory Medical Writing to join their team. This role offers a competitive salary range of $140,000 - $180,000 per annum.This individual will contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. They will also develop critical...

Job SummaryThe Chemistry Manufacturing Controls Senior Manager will play a critical role in executing global regulatory CMC strategies for investigational and marketed products. This position is responsible for leading the preparation and submission of regulatory CMC documentation, managing interactions with Health Authorities, and providing regulatory...

About BioLink 360BioLink 360 is a global leader in diagnostic imaging agents with a diverse portfolio of products. As a pioneer in the industry, we strive to maintain the highest standards of quality, safety, and compliance.OverviewThe successful candidate will direct all global pharmacovigilance activities and safety reporting for all marketed products....

Job Overview:The Regulatory Compliance Lead for Global Labeling Initiatives will play a pivotal role in ensuring Takeda Pharmaceutical's products gain regulatory approval across the globe while maintaining currency of product licenses and permits. This senior position contributes to the company's mission by guaranteeing compliance with legislation and...