Based in San Diego, CA, our client is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. We are in search of an accomplished and...
The Director of Regulatory Engagementwill work closely in collaboration with the Director of Regulatory Affairs and Director of Government Affairs to develop and implement Center for Sustainable Energy (CSE)’s regulatory and policy agendas.The Director will facilitate CSE’s regulatory engagement ...
Submits required adverse event reports. * Submits required annual reports. * Participates in Project Core Teams and provides regulatory guidance to other departments. You Bring: * B.S. degree in a ...
... and with International Regulatory Authorities. This position would be held accountable for ... Lead the coordination of regulatory meeting packages and attend Regulatory Authority meetings
Requirements Proficient in English and Chinese Bachelor's degree in biology, chemistry, or a related field. 2+ years of experience in regulatory affairs in the biotechnology industry. Knowledge of ...
MDR Technical Documentation experience (preferred) * Able to follow scientific arguments. * Good interpersonal skills. * Good oral and written communications skills. Developing negotiating skills
Develop and implement comprehensive regulatory strategies to support the clinical development, approval, and commercialization of the company's cell therapy products. * Lead interactions and ...
Hybrid Remote Full Time : Direct Hire Our client is developing the first transcatheter septal occluder with a metal-free frame, as the new standard of care for atrial septal defects. Delivered ...
Clinical Development, Data Management, Statistics, Regulatory Affairs, QA, Medical Writing, CMC, and Research * Actively support other functional groups with clinical trial set-up, maintenance and ...
A minimum of a Bachelor's degree in Science or related discipline of 5-7 years experience in IVD regulatory or similar * Certification in regulatory affairs is a bonus * Excellent understanding of ...
Assists in the preparation of agency meeting packages and strategies for agency meetings ... Travel Requirements Typically requires travel less than 5% of the time Physical Requirements and ...
Software experience (preferred) 510(k) / Q-sub / Response experience (preferred) MDR Technical ... Does the position allow for the worker to be virtual/remote? : No * Shore Options Available for ...
... Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and ... eight (8) years of progressive and relevant experience. Master's degree or PhD preferred
We are looking for a talented Regulatory Affairs Manager to join our client's team and play a crucial role in bringing new products to market. This role will be responsible for leading the regulatory ...
The Senior Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing ...
Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device ...
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectiv...
We are looking for a talented Regulatory Affairs Manager to join our client's team and play a crucial role in bringing new products to market. Qualifications of the Regulatory Affairs Manager:. An advanced degree or certification in Regulatory Affairs (e. Minimum of 5 years of regulatory affairs ...
Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met. Director, CMC Regulatory Affairs. The position is responsible for provid...
Represent Regulatory Affairs on project teams & liaise with regulatory publishing and other ancillary regulatory functions at CROs and consultants to coordinate regulatory submissions. They are seeking a Vice President of Regulatory Affairs to develop and lead global regulatory strategies for the...
Senior Regulatory Affairs Specialist - (Medical Device) - ONSITE position in. Engage with regulatory authorities and agencies to facilitate product approvals and resolve regulatory issues. Regulatory Affairs with Medical Devices. If you would like to learn more about this Regulatory Affairs Speci...
Senior Director/Executive Director, Regulatory Affairs. Meet has partnered with a pre-IPO biotech that is looking for a Head of Regulatory Affairs to join their team. Develop and execute regulatory strategies to streamline the development and approval of innovative medicines. Lead the preparation...
The Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environm...
This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Senior Director, Regulatory Affairs (Generalist). Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Aff...