Discipline

Regulatory Affairs

Regulatory Affairs Officers, CMC Regulatory Specialists and RA Managers for EU submissions, variations, lifecycle maintenance and CMC dossiers.

1 live vacancies →Request a shortlist

What a Regulatory Affairs Officer actually does

Regulatory Affairs keeps the marketing authorisation aligned with what the site actually does. An RA Officer prepares and maintains the dossier: variations when a supplier, method or specification changes, renewals, responses to questions from the agency, and the CMC sections of a new application. The role sits between QA, MSAT, the manufacturing site and the authority, and the recurring failure mode is a change implemented on the floor before the variation is approved.

CMC Regulatory Specialists go deeper into Module 3; RA Managers own the regulatory strategy for a portfolio and the relationship with the agencies. Device roles add the EU MDR and technical documentation.

What we look for when we screen

We ask about the last variation the candidate classified, why it was type IA, IB or II, and what happened when the agency disagreed. We ask which eCTD sequences they have compiled themselves and how they keep the site's change control and the dossier in step.

We also test:

Procedure literacy: centralised, decentralised, mutual recognition, national.
Lifecycle management: ICH Q12, post-approval change management protocols.
Agency interaction: response strategy, clock stops, meeting preparation.
CMC depth where relevant: comparability, specifications, stability commitments.
Working style: can you say no to a site that wants to implement a change tomorrow?

Regulations you will live with

Directive 2001/83/EC and Regulation (EC) 726/2004, the Variations Regulation 1234/2008, ICH M4 and eCTD, ICH Q12, and the EU MDR 2017/745 for devices.

Typical employers

Marketing authorisation holders, generics companies with EU portfolios, biotech companies preparing a first application, CDMOs supporting client CMC, and regulatory consultancies across the European Union.

Career path

RA Officers typically come from pharmacy, life sciences or a QA or QC background. Senior RA Officer, CMC Regulatory Specialist, RA Manager and Head of Regulatory Affairs follow; CMC and lifecycle specialists are the most requested profiles. Salary bands and interim day rates are in the salary guide.

Permanent, interim or freelance?

Permanent RA roles suit portfolios with continuous variation and renewal work. Interim and freelance demand follows submissions, acquisitions and the backlog that builds when an RA position stays empty. We place all three and tell you honestly which one your situation needs.

Salary

Indicative salary bands and interim day rates for the most common roles are in the salary guide, with the sources stated.

Salary guide →

Career path

1 RA Associate (submissions, publishing)
2 RA Officer (variations, renewals, own products)
3 Senior RA / CMC Regulatory Specialist
4 RA Manager
5 Head of Regulatory Affairs

Frequently asked questions

Do I need a pharmacy degree for Regulatory Affairs?

It helps but is not required. Life sciences, chemistry and QA or QC backgrounds are common entry routes, particularly into CMC-focused roles.

What is the difference between RA and QA?

QA controls what the site does; RA controls what the authority has approved the site to do. The two must stay in step, and the best RA Officers have spent time in QA or on the floor.

Can RA work be done remotely?

Often partly. Dossier work is desk-based, but CMC roles need regular contact with the site and its data. We state the arrangement on every vacancy.

How is an RA candidate screened before I see the CV?

A technical conversation with the founder on the work: the last variation classified, the last agency response, how the dossier and site change control are kept aligned. You receive a written note on what was tested and what convinced us.