Associate Director, Regulatory Project Management

Deputy Director of Global Regulatory Strategies—New Jersey Tanner and Associates is recruiting a Deputy Director of Global Regulatory Strategies based out of New Jersey. Responsibilities: · Planning and managing regulatory activities for regulatory projects within an assigned product area. Managing regulatory submissions for U.S. and foreign regulatory...

Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...

Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be...

The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The...

SUMMARY OF POSITION Plans, coordinates, authors and critically reviews submissions to FDA ensuring that internal consistency and consistency to relevant FDA guidelines are met. Submissions will include: Original 505(b)(2)s, pINDs, INDs, Meeting requests, ANDAs, Amendments, Supplements, Annual Reports, and other life cycle management activities. Works with...

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...

Director of Pharmacovigilance & Regulatory Affairs About the Company Our client is a market leader in diagnostic imaging agents, a global company with under 1000 employees, with HQ in Boston. The person hired will direct all global pharmacovigilance activities and safety reporting for all marketed products, and oversee internal work team activities, and...

Beacon Hill Staffing Group, LLC - Director of Regulatory Affairs - Strategy Summary of Position The Director of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. Responsibilities include defining and/or authoring compliant content for new and existing dossiers,...

Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...

S iter-Neubauer & Associates is currently conducting a search for Director of Product Management: Job Description A key position with a global industry leader in Product Realization, transforming concepts into branded products across the Communications, Healthcare, Life Sciences, Industrial, Commercial, Defense, and Aerospace markets. Overall project...

Associate Director/Director, Clinical Operations Somerset, New Jersey, United States Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms,...

Newfound Associates is a Massachusetts based executive search firm that specializes in Wealth Management recruitment. We are presently conducting a Wealth Management Director search for a well-established Northern New England Registered Investment Advisory firm with relationships throughout VT, NH, Western MA and Upstate NY. This is a planning-oriented RIA...

Job Description JOB TITLE: Director, Project Management DEPARTMENT: Information Technology - Kansas City Headquarters or Topeka General Office LOCATION: Kansas City, MO; Topeka, KS PAY GRADE: 18B PAY RANGE: Min: $125,200 - Mid: $166,900 - Max: $208,600 Scheduled Work Hours: Monday - Friday, 8:00 a.m. - 5:00 p.m. with additional work hours as needed. Summary...

Company Location: Bay AreaComp: 150K-220KPosition Reports to: VP of Regulatory and Quality Director of Regulatory Affairs - San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop...

Job Description: As a privately-owned biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first'...

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...

Director, US Regulatory Affairs Strategy Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100...

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...

Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs, you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications;...