Biologics Regulatory Affairs Director

About TakedaTakeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. By focusing our efforts on four therapeutic areas, we push the boundaries of what is possible in order to bring life-changing therapies to patients globally.At Takeda, we are transforming patient care through the...

We are seeking a talented Facilities Regulatory Affairs Strategic Lead to join our team at GSK, a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.The estimated salary for this position is $120,000 - $160,000 per year, depending on experience and qualifications. This role offers a...

About the RoleWe are seeking a highly experienced Director of Biologics Quality Assurance to provide quality oversight of our clinical development programs and manufacturing.The ideal candidate will be an expert in biologics, specifically operational QA experience with monoclonal antibodies, and have a strong background partnering with external...

Clinical Affairs Consultant Role OverviewThe Clinical Affairs Consultant role is a key position within our organization, responsible for leading the development of evidence generation strategies for assigned projects. This involves working closely with internal and external stakeholders to ensure that studies yield well-founded conclusions.Key...

Job OverviewWe are seeking a Senior Manager/Associate Director, Quality Control to join our CMC team at Third Rock Ventures Stealth NewCo. This role will lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein products across the company's pipeline.About the RoleDevelop and execute QC strategies for...

OverviewAbsorb the challenges of AbbVie's mission to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.Salary RangeThe estimated salary for this position is between $160,000 and $200,000 per year, depending on qualifications and location. In addition to a...

This is a highly challenging opportunity to lead a team in a fast-paced environment at ICON Strategic Solutions, a leading global provider of outsourced development services. The primary role of the Director, IVD Design Control and Project Management, is to oversee the scientific aspects of assay development/validation projects to meet regulatory...

About Vesalius TherapeuticsVesalius Therapeutics is a pioneering company that is revolutionizing the field of medicine by developing a platform to generate breakthrough treatments for common diseases. Our platform combines large-scale human genetics, genomics, stem cell studies, and artificial intelligence to uncover causal biology and identify optimal...

Alumni Affairs and Development at Harvard UniversityWe are seeking a highly skilled Director of Events and Advancement to join our dedicated team at Harvard University. This individual will play a key role in supporting the university's advancement activity through front-line fundraising, alumni and volunteer engagement, technology, prospect management, and...

At Charles River Laboratories, Inc., we are seeking a highly skilled Research Study Technician II to join our team. This role is a critical part of our research and development process, and we are looking for an individual who is passionate about advancing the field of biological research.Job SummaryThe Research Study Technician II will be responsible for...

About This OpportunityWe are seeking an experienced and entrepreneurial Product Lead in the Life Sciences to bring one or more therapeutics from concept to IND.ResponsibilitiesTarget Product Profiles: Develop the Target Product Profiles (TPPs) for valuable new biological therapeutics that can be discovered on our platformLead Therapeutics Programs: Oversee...

About the RoleWe are seeking an experienced Medical Director to lead our US Dermatology team. As a key member of our Medical Affairs organization, you will be responsible for developing and executing medical strategies to support our dermatology products.Key ResponsibilitiesDevelop and implement medical strategies to support product launches and lifecycle...

Job OverviewTakeda is seeking a highly experienced and skilled Global Analytical Controls Director to lead its Pharmaceutical Sciences function. This role requires a strong track record of managing global teams, developing and implementing analytical control strategies, and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and...

Job OverviewWe are seeking a highly skilled Global Clinical Operations Director to lead our clinical development planning and strategy. The successful candidate will be responsible for aspects of clinical study planning and execution within pre-specified timelines and budget.About the RoleLead and manage integration of all project team activities, leveraging...

Cambridge Health Alliance seeks a skilled and experienced professional to serve as the Senior Perioperative Nursing Director in our Perioperative Services department. This role offers an exceptional opportunity for a dedicated individual to lead a dynamic team of nurses and contribute to the delivery of high-quality patient care.About Cambridge Health...

We are seeking a board-certified and experienced Family Medicine physician to join our team as a Medical Director in an Express Care setting. Located in Massachusetts, this position offers a unique opportunity to work in a fast-paced environment with a focus on providing high-quality patient care.The ideal candidate will have a strong background in family...

Job OverviewBicycle Therapeutics is a cutting-edge biopharmaceutical company pioneering innovative medicines, known as Bicycle molecules, to tackle underserved diseases. These short peptides, constrained by small molecule scaffolds, exhibit high affinity and selectivity, making them attractive candidates for drug development.About the RoleThe Head of...

A Third Rock Ventures company is seeking a Formulations Scientist and Drug Product Lead who will be responsible for establishing core operations of a new team. This role will be a laboratory-based position and will offer opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. Responsibilities:Work collaboratively...

Job SummaryWe are seeking a Research Study Technician II for our Insourcing Solutions site in Cambridge, MA.The Research Study Technician II will be responsible for:Reviews and complies with all policies, guidelines, and operating procedures pertaining to the animal care and research program.Provides technical procedure training to less experienced staff and...

Job SummaryWe are seeking an experienced Global Pharmaceutical Science Director to lead our team in the field of analytical controls and compliance. As a key member of our organization, you will be responsible for developing and implementing strategies to control quality of drug substances and products based on current Good Laboratory/Manufacturing Practice...