Senior Regulatory Affairs Manager - Submissions & Strategy

BioSpace; Boca Raton (FL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401K with match

Medical Insurance

Vision Insurance

Life Insurance

Dental Insurance

Pet Insurance

STD/LTD

Holidays

Tuition Assistance

Shuttle Service

Job summary

ADMA Biologics in Boca Raton, FL, seeks a Manager of Regulatory Affairs to lead regulatory strategy and submission activities onsite. This role requires coordinating with multiple departments, preparing IND/BLA submissions, and ensuring compliance with FDA regulations throughout development and post-approval stages.

The candidate will manage timelines, collaborate with QA, and drive process improvements to enhance submission quality and efficiency.

Qualifications

• Bachelor’s degree in pharmaceutical/biological/chemical sciences or related field.
• Advanced degree desirable.
• Minimum regulatory experience in pharma across drug development stages.

Responsibilities

• Provide regulatory guidance to all company functions and liaise with senior management.
• Prepare, review, and evaluate regulatory submissions (INDs, BLAs, CTD, etc.).
• Define regulatory strategy and coordinate data collection across departments and vendors.
• Plan milestones, timelines, and ensure timely submissions to regulators.
• Oversee Regulatory Operations and maintain submission/tracking systems.

Skills

Regulatory strategy

Submission management

Cross-functional collaboration

Documentation

FDA regulatory knowledge

Education

Bachelor’s degree in Pharmaceutical, Biological or Chemical Science

Advanced degree desirable

Tools

Regulatory submission software

Microsoft Office

Job description

ADMA Biologics in Boca Raton, FL, seeks a Manager of Regulatory Affairs to lead regulatory strategy and submission activities onsite. This role requires coordinating with multiple departments, preparing IND/BLA submissions, and ensuring compliance with FDA regulations throughout development and post-approval stages.

The candidate will manage timelines, collaborate with QA, and drive process improvements to enhance submission quality and efficiency.