Regulatory Affairs - Preclinical Studies
This position is responsible for the strategy and oversight of the Regulatory Affairs Non-Clinical development function. 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.
Master's degree with five years of progressive and applicable experience in the area to be served required; or, an equivalent combination of education and experience. Significant experience and documented success in setting strategic direction and delivering on objectives for a business unit, company or academic unit.
- PhD/PharmD or DVM in a scientific discipline preferred along with at least 5 years of experience in industry relate
- 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
- 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
- Other duties as assigned
- 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.
Excellent oral and written communication skills
Strong project and process management skills
Knowledge of program/project management techniques and methods
Excellent organizational and leadership skills
Highly self-motivated professional with ability to work under pressure with tight deadlines
Ability to achieve results with a high level of accuracy and attention to detail
Demonstrated problem-solving and analytic skills
Ability to prioritize and manage multiple projects, work independently and in a matrix-team or collaborative setting
Outstanding knowledge of data analysis, reporting and budgeting
Working knowledge of all MS Office applications including Word and PowerPoint
Clean, comfortable, office environment
To apply for this position, please click on the "Apply Now" button on this page. You must complete the application process and then submit your application by clicking on the "Submit" button located at the bottom of the page titled "Submit Online Application". You will receive the following message once you hit the submit button: "You have successfully submitted your job application".
Computers are available for applying within the lobby of the Human Resources Department located at 1920 West First Street, (on the corner of Miller and First Street) Winston-Salem, North Carolina 27104. You may also call our office for assistance at (336) 716-6464. Office hours are Monday-Friday, 8:00am-5:00pm.
If you are an individual with a disability and need reasonable accommodation to participate in the application process, please contact our Supervisor of Office Services by phone (336) 716-3367 or email at email@example.com.
It is the policy of Wake Forest Baptist Medical Center to administer all educational and employment activities without discrimination because of race, sex, age, religion, national origin, disability, sexual orientation, gender identity or veteran status (except where sex is a bona fide occupational qualification or a statutory requirement) in accordance with all local, state, national laws, executive orders, regulations, and guidelines.
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