Certified Regulatory Affairs Specialist (CRAS)

CRAS (RAS-001) Exam Objectives

This exam certifies that the candidate has the knowledge and skills to manage the regulatory lifecycle of a pharmaceutical product in compliance with U.S. laws and regulations.

Domain 1: The Drug Development and Approval Process (35%)

• Preclinical Development: Describe the regulatory requirements for preclinical (animal) testing.
• Clinical Development: Describe the phases of clinical trials (Phase 1-4) and their regulatory purpose.
• FDA Structure and Interactions: Explain the role of the FDA and how to effectively communicate and meet with the agency.
• Expedited Programs: Differentiate between FDA's expedited approval pathways (e.g., Fast Track, Breakthrough Therapy).

Domain 2: Regulatory Submissions (30%)

• Investigational New Drug (IND) Application: Describe the components and purpose of an IND submission.
• New Drug Application (NDA) / Biologics License Application (BLA): Describe the structure (e.g., Common Technical Document) and content requirements for a marketing application.
• Lifecycle Management Submissions: Manage post-approval submissions, including supplements and annual reports.

Domain 3: Post-Marketing Compliance (25%)

• Pharmacovigilance: Describe the regulatory requirements for monitoring and reporting adverse drug events.
• Good Manufacturing Practices (GMP): Understand the role of GMP in ensuring product quality and the regulatory implications of non-compliance.
• Recalls and Market Withdrawals: Describe the regulatory process for conducting a product recall.

Domain 4: Advertising, Promotion, and Labeling (10%)

• Promotional Review: Review promotional materials to ensure they are truthful, balanced, and compliant with FDA regulations.
• Labeling: Understand the regulatory requirements for prescription drug labeling, including the Prescribing Information.

Eligibility Requirements

To be eligible to sit for a CPS certification exam, candidates must meet the criteria outlined in one of the two pathways below.

Pathway 1: For U.S. Licensed Pharmacists

This pathway is for pharmacists licensed to practice within the United States, regardless of country of graduation.

• Hold an active and unrestricted pharmacist license in any state or territory of the United States.
• Meet educational requirements by being a graduate of an ACPE-accredited school of pharmacy or holding a Foreign Pharmacy Graduate Examination Committee® (FPGEC) Certificate.
• Fulfill the specialty experience requirement as outlined below.

Pathway 2: For International Pharmacists (Non-U.S. Licensed)

This pathway is for pharmacists who practice outside of the United States.

• Hold an active and unrestricted license to practice pharmacy in their country of practice. A certified English translation of the license must be provided if the original is not in English.
• Hold a professional degree in pharmacy equivalent to a U.S. pharmacy degree, such as a Bachelor’s degree (BPharm), Master’s degree in Pharmacy Practice (MPharm), or Doctor of Pharmacy degree (PharmD).
• Fulfill the specialty experience requirement as outlined below.

Specialty Experience Requirement (for all pathways)

To ensure candidates have foundational knowledge in the specialty, one of the following criteria must be met:

• Standard Pathway:
  Completion of at least one year of professional experience in a practice setting directly related to the certification area.
• Certificate Pathway:
  The one-year specialty experience requirement is waived for candidates who hold an active certificate of completion from a nationally recognized provider in a related subject matter. This includes, but is not limited to, the completion of a relevant PGY residency, fellowship, certificate/training program, or a relevant graduate degree (e.g., a Master's degree in the specialty field). Recognized providers of certificate programs include, but are not limited to:
  • American Society of Health-System Pharmacists (ASHP)
  • American Pharmacists Association (APhA)
  • American College of Clinical Pharmacy (ACCP)
  • American Society of Consultant Pharmacists (ASCP)

Career Path for CRAS Professionals

The CRAS certification is for pharmacists seeking a career in the biopharmaceutical industry or with government agencies like the FDA. This credential demonstrates the highly specialized knowledge needed to navigate the drug approval and lifecycle management process.

Target Candidates

• Pharmacists working in the pharmaceutical industry (e.g., medical affairs, clinical development).
• Professionals with a background in quality assurance or compliance.
• Pharmacists seeking non-traditional roles in government or industry.
• Individuals with experience in preparing scientific or regulatory documentation.

Primary Job Roles:

• Regulatory Affairs Specialist / Manager
• Regulatory Strategy Lead
• Labeling Specialist
• Advertising and Promotion Reviewer
• Pharmacist at the Food and Drug Administration (FDA)

Career Advancement:

A CRAS is on a path to leadership within the regulatory field. They can advance to become a Director or Vice President of Regulatory Affairs, lead global regulatory strategy for a product portfolio, or take on senior roles within a health authority.

Study Resources

Prepare for your CRAS exam with resources designed to master the complex world of pharmaceutical regulation.