Job Postings

Date Posted

Company

Position

 The Regulatory Affairs Associate III will be a key member of the Regulatory Affairs team and interface with various Cell and Gene Therapy groups in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators). The Regulatory Affairs Associate III will work with the Quality and Regulatory groups to ensure compliance with US, EU, and ICH requirements.

  Our client is seeking an experienced, hands-on leader of Regulatory Affairs with experience and knowledge in the areas of Clinical Development as well as CMC. This individual will be supporting all Regulatory Affairs activities and the conduct of related activities across all company programs. They will also act as the lead for all Regulatory agency questions and interactions and the tracking of those activities. This individual will work closely with company executives, cross-functional leadership, and external vendors across various strategic and operational initiatives to support overall product development activities.  

 Provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.

JobID: R1197036

To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.

JobID: R1193249

  The position will be engaged in leading key aspects of Kymanox’s regulatory service offerings and supporting clients on a portfolio of two to three projects covering regulatory, engineering, and compliance challenges related to medical devices, drug products, and combination products. The Regulatory Affairs Specialist will work under the guidance of Kymanox management and with support of multiple experienced technical project managers as well as work closely with clients at their offices.

  The Senior Associate, Regulatory Affairs plays a critical role in organizing, training, and leading regulatory associate staff in handling all day-to-day regulatory operations activities for the company. The Senior Associate, Regulatory Affairs also leads or supports complex strategic regulatory activities, coordinating across functions as needed to assemble or support assembly of information from relevant disciplines to produce complete, high-quality regulatory submissions. Finally, the Senior Associate, Regulatory Affairs serves as an important consultative resource for junior Regulatory Affairs staff as well as staff in other segments of the company.