Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
University of Colorado Anschutz Medical Campus
Department: Gates Institute
Job Title: Regulatory Affairs Program Director
Position #00819327 – Requisition #32624
Job Summary:
Join the Gates Institute as a Regulatory Affairs Program Director. This is a full-time University Staff position that serves as a key contributor to the development and execution of product development within the Gates Institute. This role will be responsible for developing regulatory strategy from early discovery through Phase I clinical trials. This position will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
Key Responsibilities:
Work Location:
Why Join Us:
The opportunity offered by the Gates Institute is one of a kind. They blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50 highly dedicated people, operating on a top tier research campus – the University of Colorado – Anschutz Medical Campus.
The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. They are only limited by their resources and need you to make their journey a success!
In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients.
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, holidays and more. To see what benefits are available, please visit:Diversity and Equity:
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
Qualifications:
Minimum Qualifications:
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
Experience preparing regulatory filings for cell and gene therapy products for a pharmaceutical and/or biotechnology company.
Experience leading and participating in communications with the FDA.
Experience working with and an understanding of the unique pre-clinical, CMC and/or clinical aspects of cell therapy.
Experience managing multiple products simultaneously and at different stages of the product lifecycle.
Strong experience with eCTD format.
3 years of experience working in cell and/or gene therapy field.
Regulatory Affairs Certification (RAC)
Knowledge, Skills, and Abilities:
How to Apply:
For full consideration, please submit the following document(s):
1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position2. Resume
3. Three to five professional references including name, address, phone number (mobile number if appropriate), and email address
Questions should be directed to: Donna.3.Parker@cuanschutz.edu
Screening of Applications Begins:
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by March 10, 2024. Those who do not apply by this date may or may not be considered.
Anticipated Pay Range:
The above hiring range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.
This position is not eligible for overtime compensation.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.Total Compensation Calculator:
ADA Statement:
Background Check Statement:
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
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