EUSTM Academy · Professional Certification

PCRAProfessional Certification in Regulatory Affairs

A professional credential offered by EUSTM Academy, the professional certification body of the European Society for Translational Medicine (EUSTM) — recognising professionals with demonstrated expertise in navigating the regulatory requirements for medicines and medical technologies, from marketing authorisation and submissions to lifecycle maintenance and compliance across international frameworks.

Professional certification award
Assessment
Two pathways
Global Community
60+ countries
Credential
PCRA postnominal
Why It Matters

Certification Benefits

The PCRA title is a clear, verifiable signal that you have the professional background to prepare, manage, and maintain regulatory submissions — recognised by employers and collaborators worldwide.

1Use the PCRA postnominal title on your CV, LinkedIn, and professional correspondence.
2Demonstrate your competency to prepare, manage, and maintain regulatory submissions across regulated environments.
3Strengthen your profile for roles in pharma, biotech, medical-device, CROs, and regulatory consultancy settings.
4Increase your visibility for senior roles in regulatory affairs, regulatory strategy, and compliance.
5Support your eligibility for consultancy and advisory roles in medicines and medical-device regulation.
6Stand out in a competitive global job market with a credential from a European scientific society.
7Receive an official PCRA certificate issued by the EUSTM Academy under EUSTM accreditation.
8Hold a verifiable credential that employers and collaborators can confirm at any time.
Who Should Apply

Who Should Apply?

PCRA is designed for professionals actively involved in the regulation of medicines and medical technologies — across industry, clinical, and consultancy settings. If one of these describes you, you are eligible to apply:

Certification Categories

Two pathways to certification

After you submit the PCRA Application Form, the EUSTM Academy Educational Board reviews each application and assigns one of two categories based on your background, experience, and qualifications.

1
Category 1

Experience Pathway

For professionals with 3 or more years of relevant regulatory affairs experience — CV-based evaluation, no examination required.

  • Background & experience review — relevance and depth in regulatory submissions and regulated environments.
  • Evidence of contribution, cross-functional collaboration, and the quality of your professional statement.
2
Category 2

Examination Pathway

For early-career professionals or those transitioning into regulatory affairs — certification granted upon passing a qualifying online examination.

  • Qualifying online examination covering core regulatory affairs competencies — proctored online and available year-round.
  • Results within two weeks; a pass mark is required to qualify for certification.
Application Process

Five steps to certification

1

Submit Application

Complete the secure online application form and upload your CV. There is no application fee — your submission goes straight to the EUSTM Academy Educational Board for review.

2

Board Review

The EUSTM Academy Educational Board reviews your application and assigns Category 1 or 2.

3

Assessment

Category 1: portfolio evaluation. Category 2: qualifying online examination.

4

Conditions & Fee

Sign the Certification Conditions Form and pay the applicable fee.

5

Certificate Awarded

Receive your PCRA certificate and the right to use the postnominal title.

Certification Fees

PCRA Certification Fee

CategoryInitial CertificationAnnual Renewal
High-income countries€400€400 / year
Middle-income countries€325€325 / year
Low-income countries€250€250 / year

Country tiers follow the World Bank income classification. Annual renewal confirms your continued active engagement in regulatory affairs and your commitment to the EUSTM Code of Professional Conduct.

For further information, please contact the EUSTM Academy at [email protected].

Begin your PCRA certification journey

Apply online in minutes — complete the form and upload your CV — with no application fee — to begin your formal recognition as a certified regulatory affairs professional.

Start Your Application

Disclaimer: PCRA is an independent professional certification awarded by the EUSTM Academy and accredited by EUSTM. It is not equivalent to an educational degree or state-regulated qualification, and is granted solely on the applicant's professional profile as assessed by the EUSTM Academy Educational Board.