Regulatory Affairs Manager – Drug Development Leader

ADMA BioCenters; Boca Raton (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401K plan with employer match and immediate vesting

Medical, Vision, Life and Dental Insurance

Tuition assistance

Job summary

ADMA BioCenters in Boca Raton, Florida, is looking for a Manager, Regulatory Affairs to oversee regulatory submissions and ensure compliance with FDA regulations. The ideal candidate should have over 7 years of experience in pharmaceutical regulatory affairs and a relevant Bachelor’s degree.

This role requires effective communication skills and the ability to manage multiple projects. Benefits include a 401K plan, insurance, and paid time off.

Qualifications

• Minimum of 7 years of practical pharmaceutical regulatory experience.
• Minimum of 5 years of experience with a Master’s degree.

Responsibilities

• Provide accurate regulatory guidance to all company functions.
• Prepare, review and evaluate regulatory submissions across the product lifecycle.
• Determine regulatory strategy to align with business strategy.

Skills

Effective written and verbal communication

Collaboration

Problem-solving

Negotiation skills

Education

Bachelor’s degree in Pharmaceutical, Biological or Chemical Science

Advanced degree desirable

Tools

Office software applications

Job description

ADMA BioCenters in Boca Raton, Florida, is looking for a Manager, Regulatory Affairs to oversee regulatory submissions and ensure compliance with FDA regulations. The ideal candidate should have over 7 years of experience in pharmaceutical regulatory affairs and a relevant Bachelor’s degree.

This role requires effective communication skills and the ability to manage multiple projects. Benefits include a 401K plan, insurance, and paid time off.