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 looking for a

Regulatory Affairs Specialist

to join our team and support regulatory activities across

EMEA and LATAM . This position is adecuado for a professional with

around 3 years of experience in Regulatory Affairs , particularly with strong exposure to

CMC documentation and lifecycle management

in multinational environments.

❗ ❗ We offer a

full-time employment contract based in Madrid , starting with a

one-year fully remote assignment

on an international project, including

occasional travel to the client’s site in Alcobendas

during the first year.

Responsibilities include, but are not limited to:

Support regulatory submissions and activities across

EMEA and LATAM markets .

Prepare and maintain

regulatory dossiers , including

Module 1 and Module 3 documentation.

Contribute to

CMC regulatory strategies

and documentation.

Manage

lifecycle activities , including

variations, renewals, and post-approval changes .

Prepare and review technical documentation such as

ASMF and Quality Overall Summary (QoS).

Coordinate regulatory submissions and ensure compliance with regional regulatory requirements.

Support

interactions with health authorities

and assist in addressing regulatory queries.

Collaborate with cross-functional and international teams in a

multinational environment .





Required Qualifications:

Around 3 years of experience in Regulatory Affairs

within the pharmaceutical industry.

Strong knowledge of

CMC documentation and regulatory dossier preparation

(Modules 1 & 3).

Experience with

lifecycle management , including

variations and renewals .

Familiarity with

ASMF and QoS documentation .

Experience supporting

multi-region regulatory submissions , preferably across

EMEA and/or LATAM .

Ability to work effectively in

international and cross-functional teams .

Strong organizational skills and attention to detail.

Fluency in

English and Spanish

;

Salary starts 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.

📌 Regulatory Affairs Specialist - €35.000 A Year (Madrid)
🏢 Pqe Group
📍 Madrid