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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
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
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
integral
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 ini

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