Are you ready to join a

world leader

in the exciting and dynamic fields of the

Pharmaceutical and Medical Device industries? PQE Group

has been at the forefront of these industries

since 1998 , with

40 subsidiaries

and more than

2000 employees in Europe, Asia and the Americas.

We are seeking a

Senior Regulatory Affairs & Pharmacovigilance Specialist

to support both

local

and

international

regulatory

and

PV activities . The role combines hands-on

regulatory work

with

pharmacovigilance oversight , ensuring compliance across

Spain

and

LATAM

markets.

Key Responsibilities

Regulatory Affairs (RA): Analyze EU regulatory strategies

and provide recommendations to clients Author full technical dossiers

(Modules 1–5) from scratch Manage variations, renewals, labeling updates , and

Health Authority interactions Support

regulatory activities in LATAM markets Collaborate with

integral teams

and

international clients Pharmacovigilance (PV): Support

PV activities

and

reporting obligations

in

Spain

and

EU Ensure compliance with

local and international safety regulations Assist in

signal detection ,

risk management , and

safety documentation Coordinate with

global PV teams

to align

processes

and

reporting

Requirements 4–5 years of experience in

Regulatory Affairs

and/or

Pharmacovigilance

in

pharma

or

consultancy Strong knowledge of

EU

and





Spanish regulations Experience in

global

or

corporate regulatory/PV environments Fluency in

Spanish

and

English

(C1–C2);

Nice-to-Have

knowledge of

Italian

and/or

Portuguese Experience with

LATAM regulatory/PV activities Exposure to

Medical Devices ,

Veterinary ,

Cosmetics , or

Food Supplements Strong interest in or experience with

pharmacovigilance systems

and

processes Salary starting from

€35,000 gross per year

Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group As a member of the PQE team, you will be part of a

challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

📌 Senior Regulatory Affairs & Pharmacovigilance Specialist (Barcelona)
🏢 Pqe Group
📍 Barcelona