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Regulatory Specialist
Location:
Tucson, AZ
Description:
ABOUT CRITICAL PATH INSTITUTE (C-PATH) Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For over ten years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world. POSITION OVERVIEW C-Path is seeking an experienced regulatory professional to work independently in support of cross-functional regulatory science objectives. The Regulatory Science Specialist will report to the Director of Regulatory Science and will be broadly responsible for supporting the Regulatory Science Program functions and the Rare Neurodegenerative Diseases programs. SUPERVISORY RESPONSIBILITIES None currently CORE DUTIES/RESPONSIBILITIES Contribute to developing regulatory strategies for alignment within the organization and with regulatory agencies. Knowledge of regulatory submission requirements, regulations, and recommendations. Help resolve issues in the project plans and identify corrective actions, as needed. Promote learning and strategic approaches across C-Path. Assist in disseminating internal and external regulatory science education and training activities, including didactic and experiential training programs and activities. Assist in executing and managing strategic projects to help achieve the organizations overall goals. Help generate and disseminate meaningful regulatory intelligence across the organization to enable high quality regulatory science work. Assist in developing and contributing to regulatory documents (e.g., briefing packages, qualification plans) such as questions to regulators, regulatory history of the project, Executive Summary and conclusions. Assist in responding to regulatory inquires or requests for information from regulatory agencies. Assist in reviewing regulatory submission documents and reports to regulatory agencies and for Board of Directors. Help prepare teams for meeting with regulatory agencies. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Ability to function within a matrix organization structure with interdisciplinary cross-functional teams. Knowledge of the design, conduct, and reporting of experiments or studies relevant to the preparation of regulatory applications, e.g., the applications of novel efficacy or safety biomarkers, or preclinical models. Demonstrated in-depth knowledge of regulatory approval (specifically FDA and EMA) and the drug development process. Experience in providing regulatory support to drug development and related projects including interactions with FDA and EMA is a plus. Previous experience providing regulatory leadership in a multi-disciplinary team environment. Previous experience working with public-private partnerships and consortia, composed of academic, pharmaceutical, governmental and advocacy members. Interacts well in a matrix organization, with ability to positively influence and direct internal and external stakeholders. Effective and influential communicator, with ability to appreciate and understand cross-cultural differences and communication styles. Ability to travel 15-25 percent domestically and internationally for meetings with regulatory agencies and to consortium meetings. REQUIRED EDUCATION AND EXPERIENCE An advanced degree (MS/PharmD/PhD/MD or equivalent) in a relevant scientific field and 3+ years of related experience in biopharma, a health-related organization, or therapeutic-focused nonprofit. Broad scientific, clinical, technical and regulatory understanding of the functions involved in the development of pharmaceutical products. A background in rare neurological disorders is strongly preferred. Experience working with regulatory agencies and in regulatory science is preferred. Experience in managing drug development projects (e.g., preclinical or clinical stage development) is a plus. Critical Path Institute is an equal opportunity employer. Visit our website at www.c-path.org The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties ay be added, or this description amended at any time. Covid-19 In accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, C-Path has adopted a policy to comply with this requirement. All C-Path employees must vaccinate to safeguard the health of our employees and their families and the community at large from COVID-19. Reasonable Accommodation: Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible. Accommodations will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department. Job Posted by ApplicantPro
Company:
Critical Path Institute
Posted:
December 26 2023 on ApplicantPro
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More About this Listing: Regulatory Specialist
Regulatory Specialist is a Jobs Regulatory Affairs Specialist Job at Critical Path Institute located in Tucson AZ. Find other listings like Regulatory Specialist by searching Oodle for Jobs Regulatory Affairs Specialist Jobs.
Regulatory Specialist is a Jobs Regulatory Affairs Specialist Job at Critical Path Institute located in Tucson AZ. Find other listings like Regulatory Specialist by searching Oodle for Jobs Regulatory Affairs Specialist Jobs.