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

global 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

安全 documentation

Coordinate with

general 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

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