Program Director, Regulatory Affairs
Winston Salem, NC, USA | Wake Forest
Industry:Healthcare - Hospitals
Job Description:53 people have viewed this job
This position is responsible for the strategy and oversight of the Regulatory Affairs Non-Clinical development function at Wake Forest's Institute for Regenerative Medicine. This position will support the expanding pipeline of products in development from a regulatory perspective. This individual will provide leadership and work closely with other areas within the institute. This includes the development and implementation of regulatory strategy, ensuring timely preparation for the Non-Clinical Section of an IND, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.
A strong background in Regulatory Toxicology and pre-clinical animal studies including knowledge and understanding of Good Laboratory Practices (GLPs), guidelines, experience interacting with Regulatory Authorities, and authorship of Regulatory Correspondences is required. The successful candidate will serve as a resource to team members for the regulatory requirements to conduct development activities for regenerative medicine products and have a minimum of 5 years' experience with FDA in an applicable role. Responsibilities will also include subject matter expertise relating to preclinical pharmacology, toxicology and ADME sections of regulatory documents to include INDs (Biologics & Drugs), IDEs and other regulatory submissions and responses, as needed.
In this position the successful candidate will be responsible for driving the development of innovative preclinical/non-clinical regulatory strategies and the reparation and submission of high-quality non-clinical sections of INDs in close collaboration with our scientists and in-house RMCC Process/Product Development, Manufacturing and Quality Teams, and Collaborators.
- Represent the non-clinical regulatory function on cross-functional development teams.
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies in non-clinical effort.
- Plan, prepare and review non-clinical sections to regulatory authorities to support FDA INTERACT program, Pre-IND, Pre-IDE and early phase clinical trials.
- Lead and oversee non-clinical regulatory activities for assigned projects other applicable requirements to ensure compliance.
- Manage the non-clinical regulatory aspects of products and projects including achievement of timelines and deliverables.
- Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements.
- Monitor, analyze, and disseminate intelligence on non-clinical regulatory matters that may affect ongoing development programs.
- Provide interpretation of and advice regarding non-clinical regulations, directives, and guidance. Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to day interactions
- Coordinate and prepare non-clinical responses to requests for information from regulatory authorities
- Provide leadership and oversight of the Non-Clinical/Preclinical Regulatory Affairs.
- Provide Non-Clinical regulatory strategy in design of non-clinical development programs leading to IND enabling studies.
- Determine overall Non-clinical regulatory strategy regarding early stage clinical protocol development.
- Work closely with cross-functional teams to ensure non-clinical development programs are aligned with for early stage Clinical Trials.
- Develop and execute sound non-clinical regulatory decisions and justifications.
- Comply with all pertinent SOPs and GLP regulations.
- Represent Wake Forest Institute for Regenerative Medicine in a professional manner, foster a cooperative and team relationship with partner organizations.Other duties as assigned
- PhD/PharmD or DVM in a scientific disciplinepreferred along with at least 5 years of experience in industry relate<i Regulatory Affairs and 5 years' experience at the FDA in an applicable position.
- Knowledge and understanding of non-clinical global regulations and guidelines
- Previous experience in the preparation and submission of non-clinical regulatory documents
- Strong attention to detail and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Proven regulatory leadership experience in a cross-functional role with non-clinical product development experience.
- Strong technical knowledge of non-clinical development.
- Strong knowledge and interest in the evolving landscape of novel clinical development programs.
- Oversight of design, conduct, interpretation, and reporting of all regulatory non-clinical studies including resulting risk assessments.
- Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development.
- Coordinate toxicological/preclinical safety evaluations of development candidates with internal, external contract laboratories, consultants, faculty and RMCC.
- Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety.
- In depth understanding and working knowledge of regulatory toxicology, GlPs, and US and International Regulatory Guidelines
- Strong problem solver who is highly organized with the ability to thrive in an environment with rapidly changing priorities
- Advanced scientific writing skills.
- Experience in animal Pharm/Tox studies/models, including protocol design & study conduct
- Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guideline
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