Regulatory Affairs Specialist
The Laboratory for Cell and Gene Medicine (LCGM) is offering an exciting new professional opportunity: Regulatory Affairs Specialist; a role specifically created for its Good Manufacturing Practice (cGMP) facility. Stanford Health Care (SHC), Lucile Packard Children’s Hospital (LPCH), and the Stanford University School of Medicine (SOM) are jointly developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients. The LCGM offers a team-based approach to providing process development and manufacturing services to Stanford Medicine investigators to develop and implement leading-edge cell and gene-based therapies for Phase I and II clinical trials.
The Regulatory Affairs Specialist reports to the Associate Director of Regulatory Affairs and plays a critical role in developing and managing Investigational New Drug (IND) submissions to the IND and in creating policies and procedures to ensure compliance with US Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211); Human Cells, Tissues, and Cellular and Tissue-based Products (21 CFR Part 1271); and Biologics (21 CFR 600) regulations.
Standard Core Duties include*:
- Provide support on collaboration with investigator project teams to manage and coordinate the authoring, review, and finalization of regulatory documents in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress
- Support preparation, assembly of clinical, pre-clinical, and CMC information for submissions of Investigational New Drugs (INDs) including amendments, supplements and annual reports for multiple simultaneous submissions for manufactured products across a broad spectrum of biological systems
- Includes project/submission maintenance; templates; word processing and formatting; proof-reading; bookmarks and hyperlink publishing; and archiving for R&D regulatory documents. This position also executes and maintains processes for managing regulatory submissions, correspondences, and commitments in accordance with Good Documentation Practices. Contribute to installation and maintenance of software for regulatory submissions and documentation
- Liaise with internal teams such as process development scientists, manufacturing scientists, quality control, quality assurance and clinical research staff and operations
- Support the development of responses to Health Authority requests and ensure alignment with regulatory CMC strategy. Assist in drafting background packages for meetings with Health Authorities.
- Support facility licensing and registration, GMP validation activities of cell processing facility and other cGMP/GLP activities (change controls, QSR implementation, SOP and RMS reviews) via direct interactions with QA
- Inform training required for Regulatory Affairs staff at LCGM
* Other duties may also be assigned
- Working knowledge of US CMC regulations as well as ICH and US guidance documents required.
- Bachelor's degree in Life Sciences, advanced degree preferred.
- Experience in regulatory affairs or other relevant experience in investigational stage biologics.
- Ability to contribute to multiple projects/submissions concurrently.
- Strong interpersonal skills and the ability to work in a project team environment.
- Excellent written and oral communication skills in English.
- Strong technical writing and editing skills.
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree and 5 years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
- Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.
- Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.
- Demonstrated ability to develop and meet budget goals.
- Demonstrated solid planning and organizational skills.
- Demonstrated experience working independently and as part of a team.
- Excellent interpersonal, written and oral communication skills.
- Strong relevant subject matter knowledge.
CERTIFICATIONS & LICENSES:
- Constantly perform desk-based computer tasks.
- Frequently stand/walk, sitting, grasp lightly/fine manipulation.
- Occasionally use a telephone.
- Rarely lift/carry/push/pull objects that weigh 11-20 pounds.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.