Regulatory Affairs Manager — Submissions & Strategy

BioSpace; Boca Raton (FL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

401K plan with employer match and vest

Medical, Vision, Life and Dental

Pet Insurance

Company paid STD and LTD

Holidays & PTO

Tuition Assistance

Shuttle to Tri-Rail

Job summary

ADMA Biologics, located in Boca Raton, Florida, seeks a Manager of Regulatory Affairs to lead regulatory submissions and strategy across drug development stages. This onsite role requires coordinating with FDA and other agencies, preparing pre-IND meetings, and ensuring compliance with GMP and related guidelines.

The candidate will drive cross‑functional regulatory activities and maintain high-quality documentation.

Qualifications

• Bachelor’s degree in Pharmaceutical, Biological or Chemical Science.
• Minimum of 7 years of practical pharmaceutical regulatory expertise.
• Experience with IND, BLA and CTD submissions and regulatory filings.

Responsibilities

• Provide regulatory guidance to all company functions while coordinating with Regulatory Affairs leadership.
• Prepare, review, and evaluate regulatory submissions for INDs, BLAs and post‑marketing reports.
• Plan regulatory milestones, timelines and ensure timely, accurate submissions to authorities.
• Oversee Regulatory Operations with document controls and SOPs to ensure compliant processes.
• Collaborate with QA to perform regulatory risk assessments and mitigation planning.

Skills

Regulatory strategy

Regulatory submissions

Regulatory liaison

Regulatory operations

Education

Bachelor's degree in Pharmaceutical, Biological or Chemical Science

Advanced degree desirable

Job description

ADMA Biologics, located in Boca Raton, Florida, seeks a Manager of Regulatory Affairs to lead regulatory submissions and strategy across drug development stages. This onsite role requires coordinating with FDA and other agencies, preparing pre-IND meetings, and ensuring compliance with GMP and related guidelines.

The candidate will drive cross‑functional regulatory activities and maintain high-quality documentation.