Professional Certification

PCRAProfessional Certification in Regulatory Affairs

A professional credential offered by EUSTM Academy, an educational initiative 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.

Awarded by the EUSTM Academy — an educational initiative of the European Society for Translational Medicine (EUSTM), a non-profit scientific society registered in Vienna, Austria (ZVR 629427022), active in more than 60 countries since 2013.

PCRA

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 — a permanent, portable mark of recognised expertise.

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?

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:

Regulatory-affairs associates, officers, and managers
Professionals moving into regulatory affairs from R&D, QA, or clinical roles
Pharmacists, life scientists, and clinicians entering regulatory work
Medical-device and IVD regulatory professionals (EU MDR/IVDR)
CRO and regulatory-consultancy staff
QA and pharmacovigilance professionals with regulatory responsibilities
Regulatory operations and submissions-publishing specialists
Public-health and policy professionals working with regulatory frameworks

Application process

Applying is straightforward. Complete the secure online PCRA application form and upload your CV — your submission goes directly to the EUSTM Academy Educational Board.

The Board reviews every application and assigns one of two pathways based on your background and experience. Category 1, the Experience Pathway, is a CV and portfolio-based evaluation for established professionals — no examination required. Category 2, the Examination Pathway, is for those earlier in their career or moving into the field, with certification granted on passing a qualifying online examination (results within two weeks). If you are unsure which applies, the Board assigns your category after reviewing your application.

Once your pathway is confirmed, you sign the Certification Conditions Form and pay the applicable fee. Your PCRA certificate is then issued, together with the right to use the post-nominal title.

PCRA Certification Fee

Category	Initial Fee	Renewal
High-income countries	€350	€300 / year
All other countries	€250	€200 / 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.

Begin your PCRA certification journey

Apply online in minutes — complete the form and upload your CV — to begin your formal recognition as a certified regulatory affairs professional.

Start Your Application

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

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.