Job Summary: C-Path is seeking an experienced regulatory professional to assume the following responsibilities in support of C-Path's consortium environment.
Essential Job Duties and Responsibilities
Consortia Regulatory Support:
Influence project team's thinking beyond the scientific research to identify desired regulatory outcomes, see regulatory perspective, and develop objectives and action plans for regulatory pathways the team will pu Advise on regulatory timing and procedural steps for projects.
Help resolve issues in the project's regulatory plans and identify responses and corrective action if needed.
Provide direction on and interpretation of regulatory guidance/policy requirements, regulatory intelligence; ability to represent the regulators' perspective on project goals and objectives as well as scientific data generated.
Promote learning and strategic approaches across C-Path consortia by timely communication of regulatory success and challenges and prior experience in dealing with regulatory agencies.
Effective Regulatory Communication:
Lead/contribute to on-going communications with regulatory agencies involved on the project.
Develop/contribute 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.
Coordination and preparation of responses to regulatory inquires or request for information from regulatory agencies.
Overall regulatory review and editing of all documents for submission to regulatory agencies to improve overall organization, flow, and consistent messaging.
Preparation, editing and review of slide sets used for regulatory meetings for clarity and consistency of messaging to regulators.
Help prepare teams for meeting 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).
Develop trusting relationship with contacts at regulatory agencies.
Ability to lead meetings with regulatory agencies as required.
An advanced degree in a scientific or medical discipline.
Experience in drug development (drug discovery, mechanistic pharmacology, safety assessment, clinical development, project management or regulatory affairs in the pharmaceutical industry and/or FDA/EMA).
Broad scientific, clinical, technical and regulatory understanding of the functions involved in the development of pharmaceutical products.
Ability to operate within a matrix organization structure with interdisciplinary cross-functional teams.
Familiarity with the design, conduct, and reporting of experiments or studies relevant to the preparation of IND applications: for example, the applications of novel efficacy or safety biomarkers, or preclinical efficacy models.
Demonstrated in-depth knowledge of regulatory approval and the drug development process.
Demonstrated in-depth knowledge of FDA/EMA/PMDA regulations and requirements.
Working knowledge of good clinical practices.
Working knowledge of assay development and validation, and bio-statistical analysis.
Experience, ideally recent, in providing regulatory support to drug development and related projects including interactions with FDA and EMA. EMA.
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
Nestled in the foothills of the Catalina mountains in Tucson, is a nonprofit engaged in world-changing work every day. Imagine a role where everything you do plays a part in the creation of partnerships and innovative processes that have substantial human impact. You'll work with brilliant people who are committed to the collaborative process and our mission. For over ten years, we have partnered... with industry and academic experts to advance technologies that encompass the entire spectrum of 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 to improve drug development and regulatory processes to get new products to patients quicker and at more affordable price points. Our continuing success is made possible by a combination of public and private support who share our vision to accelerate a path to a healthier world.