C-Path is seeking an experienced regulatory professional to assume the following responsibilities in support of C-Path's Regulatory Science operations.
There are no supervisory responsibilities.
In partnership with the Director of Regulatory Science, facilitate cross-organizational communications and coordinating regulatory and scientific strategies to align within C-Path and with the regulatory agencies. The Regulatory Scientist will contribute to developing regulatory strategies, should have knowledge of regulatory submission requirements and recommendations, and interpret published regulations pertinent to the projects
Help identify gaps and challenges, implement corrective measures as appropriate, for efficient and effective execution of the project's regulatory plans and identify responses and corrective action if needed.
Promote learning and strategic approaches across C-Path consortia by timely communication of regulatory successes and challenges and prior experience in dealing with regulatory agencies.
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 organization's overall goals.
Help generate and disseminate meaningful regulatory intelligence across the organization to enable high quality regulatory science work.
Facilitate robust cross-organization communications and shared regulatory learnings.
Assist in developing and contributing to regulatory focused sections of 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 request for information from regulatory agencies.
Assist in reviewing slide presentations and submission documents for regulatory agencies to improve overall clarity, organization, and flow.
Assist in reviewing reports to regulatory agencies and for Board of Directors meetings to improve overall clarity and ensure consortia impact is well-articulated.
Help prepare teams for meetings with regulatory agencies (e.g., develop clear agendas, manage meeting preparation sessions for meeting attendees, provide regulator's perspective on potential reactions/questions on the project).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Ability to operate 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 is a plus.
Working knowledge of good clinical practices.
Working knowledge of assay development and validation, and biostatistical analysis.
Experience, ideally recent, 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 with consortia, composed of academic, pharmaceutical, governmental and advocacy members is a plus.
Interacts well in a matrix organization, with ability to positively influence and direct internal and external stakeholders.
Demonstrated ability to prioritize across several working group projects.
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 or equivalent is acceptable, PharmD/PhD/MD or equivalent is preferred) in a relevant scientific field and 3+ years of related experience in biopharma, a health-related organization, or therapeutic-focused nonprofit.
A background in rare neurological disorders is strongly preferred.
Experience in regulatory science is preferred.
Experience in managing drug development projects (e.g., preclinical or clinical stage development) is a plus.
Broad scientific, clinical, technical and regulatory understanding of the functions involved in the development of pharmaceutical products
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 fifteen 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.