Regulatory Affairs Director

About the RoleThe International Medical Director will serve as a subject matter expert for our products and related data within a therapeutic area. This role requires a team player with prior research experience, either in academia or industry, to develop products within the Novel Modalities team working with the ATTR cardiomyopathy project. The...

Voyager Therapeutics, Inc. is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of - and ultimately cure - neurological diseases.Our pipeline includes programs for Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple other diseases of the central nervous system.Many of our...

Job Title: Associate Director, Analytical Development, Bioanalytics Late StageAt BioSpace, Inc., we are seeking a highly skilled and experienced Associate Director to lead our Analytical Development team in the Bioanalytics Late Stage area. The successful candidate will be responsible for independently conducting technical analyses and risk assessments to...

About the RoleThe International Medical Director will serve as a subject matter expert for our products and related data within a therapeutic area. This role requires a team player with prior research experience, either in academia or industry, to help develop products within the Novel Modalities team working with the ATTR cardiomyopathy project.Key...

Job DescriptionThe Medical Monitor is a key member of the clinical development team responsible for planning, conducting, analyzing, and reporting clinical studies. This role requires working independently across functional teams and leading/managing others to ensure timely execution of the clinical development plan.The successful candidate will work closely...

Job Title: Associate Director, US 3PL Operations Management LeadAbout the Role:As a key member of our team, you will be responsible for providing oversight and leadership of US 3PL/LSP operations to support main GSC operational goals. This includes Risk Management, Product Quality, Cost Management, Service Requirements, Compliance, New Product Launch...

About GenezenGenezen is a cutting-edge biotechnology company committed to delivering innovative gene therapies. With a strong focus on scientific excellence, we strive to accelerate treatments for patients.Our CommitmentWe operate with urgency and a commitment to delivering timely treatments by accelerating our partners' programs. Our team is dedicated to...

Job SummaryReporting to the Chief Financial Officer, this role will lead Kiniksa's investor relations and corporate communications strategy. Working closely with executive leadership, the Vice President of Investor Relations & Corporate Communications will collaborate internally with a team that includes clinical, commercial, finance, regulatory, and legal...

About the RoleTakeda Pharmaceutical is seeking a highly skilled Data Scientist to join our team. As a Data Scientist, you will work closely with our drug product scientists, device engineers, test engineers, and process development experts to develop and validate computational techniques and simulations to model and predict the behavior and interaction of...

Director, Regulatory Affairs, CMC Location: Lexington, MA Education level: Master or PhD Job category: Regulatory Affairs Target start date: 12/1/2024 Work Location: Hybrid Shift: 1st uniQure is delivering on the promise of gene therapy - single treatments with potentially curative results. We are leveraging our modular and validated technology...

We have the great pleasure of helping a global client to source a Senior Director of Regulatory Affairs. Our client is a specialist diagnostic Medical Device organisation, a global leader in innovative product development and advancement. Due to an exciting growth trajectory, they are looking for this individual to join the leadership team at this critical...

We have the great pleasure of helping a global client to source a Senior Director of Regulatory Affairs. Our client is a specialist diagnostic Medical Device organisation, a global leader in innovative product development and advancement. Due to an exciting growth trajectory, they are looking for this individual to join the leadership team at this critical...

We have the great pleasure of helping a global client to source a Senior Director of Regulatory Affairs. Our client is a specialist diagnostic Medical Device organisation, a global leader in innovative product development and advancement. Due to an exciting growth trajectory, they are looking for this individual to join the leadership team at this critical...

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

As a key member of the Takeda Development Center Americas, Inc. team, you will play a critical role in ensuring the successful submission of CMC dossiers for advanced therapies and biological compounds. Your expertise in global CMC regulations will be essential in developing and maintaining strong working relationships with the regulatory CMC team and...

Title: Senior Manager, US Medical Ad/Promo Regulatory ReviewAbout the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will also provide regulatory strategic...

Title: Senior Manager, US Medical Ad/Promo Regulatory ReviewAbout the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will also provide regulatory strategic...

Title: Senior Manager, US Medical Ad/Promo Regulatory ReviewAbout the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will also provide regulatory strategic...

Job Summary We are seeking a highly experienced and skilled Senior Director of CMC Strategy to join our team at Kiniksa Pharmaceuticals. The successful candidate will be responsible for establishing overall CMC development strategies and timelines for all programs, working closely with the Tech Ops Core Team leads and external partners. This is a senior...

Title: Senior Manager, US Medical Ad/Promo Regulatory ReviewAbout the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will also provide regulatory strategic...

Job DescriptionJob DescriptionClinical QA Contractor (AD/Director level)  Job Title: Clinical QA Contractor (Associate Director/Director Level)Location: Lexington, MARemote Flexibility: Hybrid remote – they want someone in office Tuesdays and ThursdaysContract Term: Minimum 6 monthsExperience required: Bachelor’s Degree, preferably in a scientific...

Job DescriptionAt Takeda, we are seeking a highly skilled Director, Medical Communications and Scientific Training – Immunology/Dermatology to lead our medical communications and scientific training efforts in the immunology/dermatology therapeutic area. This role will be based out of our Lexington, MA office and will report to the Sr. Director of Medical...

Job Summary:The Regional Account Director will serve as the primary point of contact for assigned key accounts, including hospital systems, VISN, and local Veterans Affairs facilities. This role will develop relationships with key decision makers to represent the interests of Indivior and its portfolio. The incumbent will also identify and develop new...

Job DescriptionKentucky Educational Television (KET) is seeking a highly skilled and experienced Chief Administrative Officer to join its team at the Lexington, Kentucky Network Center. As a key member of the organization, you will play a vital role in supporting the Executive Director & CEO in the administrative oversight of human resources, finances,...

Job SummaryWe are seeking a highly skilled and experienced Supervisory Medical Technologist to join our team at the Veterans Affairs, Veterans Health Administration. This is a full-time, permanent position responsible for supervising and managing a team of medical technologists in the clinical microbiology and chemistry laboratories.Key ResponsibilitiesPlan...

Job Summary:The Regional Account Director will serve as the primary point of contact within assigned key accounts, including hospital systems, VISN and local Veterans Affairs facilities, integrated delivery networks or other key institutional accounts that have been identified to possess a high potential/high impact presence in a broad segment of the...

Job SummaryThe Director of Nursing at CHI Saint Joseph Hospital is responsible for ensuring the highest quality care and experience for our patients while prioritizing the safety and satisfaction of our team members.This role involves communicating the organization's goals to nursing staff, seeking to improve patient experiences, reaching out to our...

Job Title: Director of Criminal Justice ProgramsJob Summary: The University of Kentucky seeks a visionary leader to serve as the Director of Criminal Justice Programs. Reporting to the Dean and receiving oversight from the Associate Dean of Academic and Student Affairs, the successful candidate will provide strategic leadership and oversight for all aspects...