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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

integral 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 you

📌 Senior Regulatory Affairs (Barcelona)
🏢 Pqe Group
📍 Barcelona