Education Requirements: Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Master’s degree preferred.
Experience Requirements: 7-10 years experience in Biologic Regulatory Affairs function with FDA, cGMP and cGCP experience. Experience with both personnel and project management. CBER and BLA experience is essential.
General knowledge of pharmaceutical development and federal regulations in pharmaceutical principles of document management.
Excellent program management skills.
Proficient in word processing packages.
Must be able to represent the company with accuracy and sensitivity to regulatory issues.
Detailed knowledge of: Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines; and Regulatory Affairs department SOPs.
Frequent contact with interdepartmental staff and management to exchange information, coordinate projects and problem solve.
Regular contact with consultants and FDA representatives to exchange information and coordinate projects.
May have direct responsibility for supervision of support staff. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises good judgement as erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
Regularly interacts with management on matters concerning several functional areas, divisions, and/or customers.
The majority of decisions will be based on pre-established policies/procedures and/or regulatory agency requirements.
Balance multiple projects. Step-in to fill-in/take over ongoing projects with minimal notice. Multiple deadlines on conflicting projects.
Physical Demands: Sits at desk 70% of time operating PC. Thirty percent of time spent conversing with management and consultants.
Employer will assist with relocation costs.
Internal Number: 00001
About ADMA Biologics
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this undeserved population that fuels us, and our hands-on approach to production and development that sets us apart.