Manager, Regulatory Affairs
BioSpace17 hours ago
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OnsiteFull-timeSenior
Summary
ADMA Biologics is seeking a Manager, Regulatory Affairs to join their team in Boca Raton, FL. The role involves supervising and participating in the planning, preparation, and evaluation of regulatory documents for submission to governmental regulatory agencies.
About the Role
As a Manager, Regulatory Affairs, you will serve as a liaison with regulatory agencies and contractors, ensuring corporate policies comply with regulatory requirements. You will provide regulatory guidance, prepare and review submissions, determine regulatory strategies, oversee regulatory operations, and keep abreast of new laws and regulations impacting company products.
About You
Required:
- Minimum of 7 years of practical pharmaceutical regulatory expertise across phases of drug development.
- Bachelor's degree in Pharmaceutical, Biological or Chemical Science or related field.
Preferred:
- Minimum of 5 years’ experience with Master’s degree.
- Effective written and verbal communication, collaboration, problem-solving, and negotiation skills.
- General knowledge of Good Manufacturing Practices, Good Clinical Practices, Good Documentation Practices, and Good Laboratory Practices.
Benefits
- 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.
BioSpace
BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.
Boca Raton, FL