Senior Regulatory Executive

hace 7 días

Barcelona, España G&L Healthcare Advisors A tiempo completo

Contract: Permanent Full-Time

Closing Date: 31/10/25

We are a specialist consultancy providing regulatory expertise to leading global pharmaceutical and healthcare organisations. We are currently seeking an experienced Senior Regulatory Executive (CMC RA Devices) to support one of our major clients on a contract basis.

In this role, you will contribute to the preparation and maintenance of Design History Files and Technical Files for combination products and medical devices, ensuring they meet the latest regulatory standards across the US FDA and EU EMA territories.

This is a hands-on role where you will work collaboratively with cross-functional stakeholders, managing documentation to a high standard of accuracy and compliance while navigating evolving regulatory requirements.

**The Role**:
**Key Responsibilities**:

- Prepare and update Design History Files for inhaled and injectable combination products to current US/EU regulatory standards.
- Contribute to the compilation of GSPR checklists for devices.
- Support regulatory strategy planning for combination product submissions.
- Assist in risk assessment processes.
- Review, update, and draft new SOPs to capture best practices and ways of working.

**Requirements**:
**Required Skills & Experience**:

- Strong background in CMC-based regulatory affairs for medical devices/combination products.
- Lifesciences degree.
- Excellent written and verbal communication skills.
- Strong attention to detail with the ability to manage critical documentation.
- Proven ability to work effectively as part of a global, cross-functional team.
- Strong organisational and time management skills.
- Problem-solving mindset and ability to adapt to changing priorities.
- Global regulatory experience, with emphasis on US and EU requirements.
- Experience with lifecycle management of medical devices and combination products.
- Familiarity with document management systems such as Veeva Vault.

**Why Join Us?**

This role offers the opportunity to work at the forefront of global drug development while embedded with a top-tier pharmaceutical client.

You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants.

**How to Apply**:
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

  • Executive Director, Global Regulatory Science

    hace 1 semana

    Barcelona, España AstraZeneca A tiempo completo

    Are you a strategically focused Regulatory professional with global leadership experience that would like to play an integral part in bringing life changing oncology medicines to patients? If you are please read on..._ AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that discovers, develops and commercializes ground-breaking...

  • Senior Director, Regulatory Inspection Excellence

    hace 1 semana

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (on-site 3 days/week working from the office)** The Senior Director, Regulatory Inspection Excellence & Readiness is a critical leadership role within Patient Safety, responsible for global organisational preparedness for regulatory, affiliate, and licensing partner inspections and audits. The role directs a global team to...

  • French Regulatory Case Executive

    hace 1 día

    Barcelona, España eDreams ODIGEO A tiempo completo

    A leading travel tech company in Barcelona is seeking an experienced Regulatory Case Executive to manage consumer regulatory complaints. This role involves collaborating with Legal teams and supports various VIP tasks while offering a flexible hybrid work environment. Candidates should possess excellent communication skills in French and a proficient level...

  • French Regulatory Case Executive – VIP

    hace 1 semana

    barcelona, España eDreams ODIGEO A tiempo completo

    A leading travel tech company in Barcelona is seeking an experienced Regulatory Case Executive to manage consumer regulatory complaints. This role involves collaborating with Legal teams and supports various VIP tasks while offering a flexible hybrid work environment. Candidates should possess excellent communication skills in French and a proficient level...

  • Regulatory Cases Executive

    hace 1 semana

    Barcelona, España eDreams ODIGEO A tiempo completo

    Regulatory Case Executive (Spanish)As you contemplate your future, you might be asking yourself, what's the next step? Start your journey with us! We’re seeking an experienced Regulatory Case Executive to join our eDreams ODIGEO Communications team, which is in a strong growth environment and will be based in our Barcelona office. The role reports directly...

  • French Regulatory Case Executive – VIP

    hace 4 días

    Barcelona, España eDreams ODIGEO A tiempo completo

    A leading travel tech company in Barcelona is seeking an experienced Regulatory Case Executive to manage consumer regulatory complaints.¿Es este el siguiente paso en su carrera? Descubra si es el candidato adecuado leyendo la descripción completa a continuación.This role involves collaborating with Legal teams and supports various VIP tasks while offering...

  • Senior Regulatory Affairs

    hace 1 semana

    Barcelona, España Antal International A tiempo completo

    Desde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en Barcelona. **Requisitos**: - Formación Universitaria en Ciencias de la Salud - Más de 4 años con posiciones de Regulatory...

  • Regulatory Cases Executive

    hace 1 semana

    barcelona, España eDreams ODIGEO A tiempo completo

    Regulatory Case Executive (Spanish) As you contemplate your future, you might be asking yourself, what's the next step? Start your journey with us! We’re seeking an experienced Regulatory Case Executive to join our eDreams ODIGEO Communications team, which is in a strong growth environment and will be based in our Barcelona office. The role reports...

  • Senior Regulatory Legal Counsel

    hace 3 días

    Barcelona, España Thunes A tiempo completo

    **About Thunes** Thunes is a global, fast-growing, and innovative Fintech scale-up that uses technology to disrupt and transform the existing financial system. We are proud to power payments for the world's fastest-growing businesses and work with some of the amazing global brands - from Gig Economy giants such as Uber and Deliveroo and Southeast Asia's...

  • Senior Executive Search Consultant

    hace 23 horas

    Barcelona, España Loftus Bradford Executive Search S.L A tiempo completo

    About the company Loftus Bradford Executive Search is one of the fastest-growing executive search firms in the world. Based in Barcelona, Spain, we are a youthful, vibrant, energetic, and diverse team with a global reputation for delivering superior results on behalf of our clients. We don’t only match the world’s strongest leaders to the world’s most...