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Manager Rac Regulatory Affairs Certification Jobs

LHH US

Senior Regulatory Affairs Specialist

Dublin, CA

$100K - $150K/yr

Strong project management, communication, and technical writing skills Preferred * Regulatory Affairs Certification (RAC) * Experience with digital health or SaMD Equal Opportunity Employer/Veterans ...

CEDENT

Regulatory Affairs Consultant

Dallas, TX

Advanced degree (e.g., Master's, PhD, or Regulatory Affairs Certification (RAC)) is a plus ... management system standards. - Strong understanding of clinical trial design and the role of ...

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How much do manager rac regulatory affairs certification jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for manager rac regulatory affairs certification in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

How difficult is the RAC exam?

The RAC (Regulatory Affairs Certification) exam is considered challenging, requiring a thorough understanding of regulatory principles, laws, and industry standards. It typically involves multiple-choice questions and may require several months of study and preparation to pass successfully.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs typically include senior director or vice president positions, such as Regulatory Affairs Vice President or Head of Regulatory Affairs, which can offer salaries exceeding $200,000 annually. These roles require extensive experience, leadership skills, and often a master's degree or higher in a related field, along with certifications like RAC (Regulatory Affairs Certification).

How much does a regulatory affairs manager make at Pfizer?

A regulatory affairs manager at Pfizer typically earns between $110,000 and $150,000 annually, depending on experience, location, and level of certification. The role requires knowledge of regulatory guidelines and often involves managing compliance for pharmaceutical products.

What is the best regulatory affairs certification?

For a Manager in Regulatory Affairs, the Certified Regulatory Affairs Professional (RAC) is widely recognized as the leading certification, demonstrating expertise in regulatory processes across industries such as pharmaceuticals, medical devices, and biotech. The RAC is offered by the Regulatory Affairs Professionals Society (RAPS) and is often required or preferred for advanced roles in regulatory management. Other relevant certifications include the Regulatory Affairs Certification (RAC) in specific regions or fields and specialized training in regulatory strategies and compliance tools.
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Manager Rac Regulatory Affairs Certification jobs near you
Clinical SME I

Clinical SME I

Oran Inc

Herndon, VA • Remote

Full-time

Posted 20 days ago

Job description

Position Title

Clinical SME I

Overview

We are seeking a Clinical Subject Matter Expert (SME) with extensive experience in clinical trial operations, FDA regulatory processes, and protocol development. The ideal candidate will provide scientific and regulatory expertise supporting clinical research and healthcare initiatives.

Key Responsibilities
  • Review and analyze clinical trial protocols and regulatory documentation.
  • Provide guidance on FDA regulatory requirements and ICH guidelines.
  • Support protocol development, study design, and safety review processes.
  • Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments.
  • Collaborate with clinical, regulatory, and technical teams.
  • Assist in pharmacovigilance and informed consent review activities.
  • Provide subject matter expertise for healthcare and clinical research initiatives.
  • Ensure compliance with applicable federal and clinical research regulations.
Required Qualifications
  • Advanced degree preferred:
    • MD
    • PharmD
    • RN
    • MPH
    • MS in Clinical Research
    • Related clinical/scientific discipline
  • Minimum 10 years of relevant clinical research or regulatory experience.
  • Deep understanding of:
    • Clinical trial protocols
    • FDA regulatory review processes
    • Drug development lifecycle
    • Safety review
    • Protocol design
Required Skills
  • Clinical protocol review
  • ICH guidelines
  • FDA regulatory processes
  • Pharmacovigilance
  • Study design
  • Endpoint analysis
  • Risk-benefit evaluation
  • Informed consent review
Preferred Qualifications
  • RAC (Regulatory Affairs Certification)
  • Active clinical licensure preferred.