Wake Forest Baptist Health
Job Title: Asst Dir, WFIRM Reg Affairs
Job ID: 2659
Full/Part Time: Full-Time
Job Category: Professional / ManagementWinston-Salem, NCProfessional / Management, Medical, Healthcare5/20/2013Institute for Regenerative MedicineFull-time regular, 40 hours/weekJob Summary: Wake Forest Institute for Regenerative Medicine is seeking an Assistant Director of Regulatory Affairs for an exciting new opportunity. WFIRM is one of the world''''s leading Regenerative Medicine Institutes....http://www.wakehealth.edu/HR/Asst-Dir,-WFIRM-Reg-Affairs-2659.htm
Institute for Regenerative Medicine
Full-time regular, 40 hours/week
Job Summary: Wake Forest Institute for Regenerative Medicine is seeking an Assistant Director of Regulatory Affairs for an exciting new opportunity. WFIRM is one of the world's leading Regenerative Medicine Institutes. The new member of the team will be charged with training, monitoring and leading the organization through the FDA process of approval for projects. The position requires a minimum of eight years experience in the fields of pharmaceutical, medical device, biotechnology or cellular therapy. It also requires a thorough understanding of GCP and GMP compliance. Must have documented experience in bringing projects successfully through the FDA process utilizing GCP, GTP and GMP.
BS required, MS or PhD preferred, in the biologic sciences or related field
Skills and Qualifications:
- Minimum of eight years experience in the fields of pharmaceutical, medical device, biotechnology or cellular therapy
- Bachelor's degree with 15 years+ experience with substantial management experience will be considered
- Prior quality systems experience within a cGTP/cGMP regulated biotech, cell processing (i.e. stem cell or bone marrow processing), tissue bank or pharmaceutical company preferred. It also requires a thorough understanding of GLP, GTP, GMP and GCP compliance. Must have documented experience in bringing projects successfully through the FDA process utilizing GLP, GTP, GMP and GCP
8727 Assistant Director, WFIRM Regulatory Affairs
Job Summary: This position will be responsible for developing, planning and overseeing Wake Forest Institute for Regenerative Medicine regulatory activities. It will develop and implement strategies with a goal of obtaining regulatory submission approval for WFIRM projects. It is responsible for overseeing regulatory documentation and training efforts and ensuring all submissions comply with FDA and/or international regulations and standards.
Education/Experience: Bachelor?s degree in biological sciences or related field with 8 years of experience in pharmaceutical, medical device, biotechnology or cellular therapy area(s). Masters or PhD preferred with equivalent experience requirements. A bachelor?s degree and 10+ years of substantial management experience may be considered in lieu of experience a pharmaceutical, medical device, biotechnology or cellular therapy area. Prior quality systems experience within a cGTP/cGMP regulated biotech, cell processing (i.e. stem cell or bone marrow processing), tissue bank or pharmaceutical company preferred.
Reports To: Associate Director, Translational Research
Licensure, Certification and / or Registration:
1. Oversee all regulatory aspects for projects and products. Ensure regulatory submissions are complete, properly formatted, and are in compliance with applicable regulatory requirements.
2. Develop effective proactive regulatory strategies for global product development, regulatory agency questions, or labeling issues. Recommend strategies to management and team members.
3. Prepare and submit regulatory documents to the FDA, IRB, and other regulatory authorities including but not limited to, original IND/IDE applications, amendments, annual reports, and IND/IDE safety reports.
4. Interact directly with internal and external personnel. Represent the department in interactions with government regulatory personnel, including scientific reviewers, administrative staff and management to facilitate the review and approval of regulatory applications, and plan and facilitate formal meetings and teleconferences with regulatory authorities.
5. Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact the department?s products and operations. Advise personnel in other departments regarding applicability and impact.
6. Assist in developing operating procedures in compliance with GLP, GTP, GMP and GCP requirements.
7. Participate as a team member on each project team to ensure timelines are met.
8. Manage outside contractors contributing to regulatory packages.
9. Oversee and execute all clinical regulatory aspects for clinical trials, including the creation of reporting forms, progress reports, and other typical functions consistent with those performed by clinical research organizations.
10. Maintains substantial current technical knowledge related to all procedures relevant to WFIRM technologies in development.
11. Performs additional job related duties as required.
Skills and Qualifications:
Requires a thorough understanding of GLP, GTP, GMP and GCP compliance
Documented experience in bringing projects successfully through the FDA process utilizing GLP, GTP, GMP and GCP
Excellent time management and organizational skills, demonstrated ability to manage prioritize multiple projects and meet deadlines
Excellent written and verbal communication skills
Amount of time spent performing the following activities:
0% 35% 65%
to to to
35% 65% 100% N/A Activity
X Reaching with arms
X Finger and hand dexterity
Lifting, carrying, pushing and or pulling:
X 20 lbs. maximum
X 50 lbs. maximum
X 100 lbs. maximum
Office and lab setting
Clean, well-lit climate
Exposure to bloodborne pathogens, chemicals, research animals
May be subject to evening or weekend hours and some overnight travel may be required.
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) 716-0175. 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 firstname.lastname@example.org.
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 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.