Manager, Regulatory Affairs - Adma Biomanufacturing Llc
Boca Raton, FL 33487
About the Job
Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Master’s degree preferred.
Experience Requirements:
Minimum 5 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.
Effective written and verbal communication skills
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.
In addition to competitive compensation, we offer a comprehensive benefits package including:
401K plan with employer match and immediate vesting
Medical, Vision, Life and Dental Insurance
Pet Insurance
Company paid STD and LTD
Company Paid Holidays
3 Weeks’ Paid Time Off (within the first year)
Tuition Assistance (after the first year)
Easily accessible to Tri-Rail
Free shuttle to the Boca Tri-Rail station
ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.