Manager, Regulatory Affairs

Initial Therapeutics, Inc.; Boca Raton (FL); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

401(k) plan with employer match

Medical, Vision, Life and Dental Insurance

Pet Insurance

Company paid STD and LTD

3 Weeks’ Paid Time Off

Tuition Assistance

Free shuttle to the Boca Tri-Rail station

Job summary

Initial Therapeutics, Inc. is seeking a Manager of Regulatory Affairs to oversee regulatory document preparation and ensure compliance with FDA regulations. The role involves working closely with cross-functional teams, preparing submissions, and advising management on regulatory challenges.

Ideal candidates possess a Bachelor’s degree and at least 7 years of pharmaceutical regulatory experience. The position offers comprehensive benefits including 401(k) with employer match, medical insurance, and paid time off.

Qualifications

• Minimum of 7 years of practical pharmaceutical regulatory expertise across drug development phases.
• Minimum of 5 years’ experience with a Master’s degree.

Responsibilities

• Provides accurate and timely regulatory guidance to all company functions.
• Responsible for preparation, review, and evaluation of all regulatory submissions.
• Determines regulatory strategy that aligns with business strategy.
• Plans regulatory milestones and sets timelines for submissions.
• Oversees Regulatory Operations and implements process improvement initiatives.

Skills

Effective written and verbal communication

Collaboration

Problem-solving

Negotiation skills

Proficient in common office software applications

Education

Bachelor’s degree in Pharmaceutical, Biological, Chemical Science or related field

Advanced degree desirable

Job description

Manager, Regulatory Affairs

Location: Boca Raton, Florida (onsite, in‑person)

Position Summary

The Manager, Regulatory Affairs supervises and participates in planning, preparing, and evaluating regulatory documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration. The role serves as a liaison with regulatory agencies and contractors, provides regulatory guidance to cross‑functional teams, and ensures corporate policies comply with regulatory requirements.

Essential Functions (ES) and Responsibilities

• Provides accurate and timely regulatory guidance to all company functions while maintaining frequent contact with the Associate Director of Regulatory Affairs.
• Responsible for preparation, review, presentation, and evaluation of all regulatory submissions, including pre‑application, new application, maintenance, and post‑marketing submissions.
• Determines regulatory strategy that aligns with business strategy, defines submission requirements, and coordinates data collection from relevant departments, facilities, and contractors.
• Plans regulatory milestones, sets timelines, and assures timely, accurate, and complete submissions. Provides signatory approval for reports and amendments to INDs or BLAs. Advises senior regulatory management of potential challenges.
• Oversees Regulatory Operations by developing or maintaining project timelines, submission tracking systems, and document archive systems. Implements process improvement initiatives by revising policies, SOPs, and work instructions.
• Works closely with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices, recommending risk mitigation strategies and contingency plans.

Education & Experience Requirements

• Education Requirements: Bachelor’s degree in Pharmaceutical, Biological, Chemical Science or related field. Advanced degree desirable.
• Experience Requirements:
• Minimum of 7 years of practical pharmaceutical regulatory expertise across drug development phases.
• Minimum of 5 years’ experience with a Master’s degree.

Preferred Experience

• 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.
• Excellent program management skills.
• Proficient in common office software applications.
• Ability to represent ADMA Biologics with accuracy and sensitivity to regulatory issues.
• Detailed knowledge of U.S. Federal Food, Drug and Cosmetic Act, Code of Federal Regulations, FDA guidelines, and international harmonization standards.
• Expert knowledge of Regulatory Affairs department SOPs.
• Ability to balance multiple projects and step in to take over ongoing projects with minimal notice.
• Experience managing multiple deadlines on conflicting projects with constant interruptions.

Compliance Requirements

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, adherence to data privacy regulations, proactive participation in compliance reviews, prompt reporting of potential issues, and ongoing education to stay updated on relevant FDA regulations.

Benefits

• 401(k) 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)
• Free shuttle to the Boca Tri‑Rail station

Equal Opportunity Employer

ADMA Biologics is an Equal Opportunity Employer.