Global Regulatory Sciences

Oxford Global Resources; Madrid; Híbrido; EUR 39.000 - 42.000; Jornada completa

Descripción de la vacante

A leading company is seeking a Global Regulatory Sciences Specialist to support regulatory activities for pharmaceutical products. This role involves managing regulatory submissions, collaborating with cross-functional teams, and ensuring compliance with EU and Spanish regulations. Ideal candidates will have strong experience in regulatory affairs and fluency in both Spanish and English.

Servicios

Medical Insurance

Formación

• Minimum 2-3 years of experience in Regulatory Affairs.
• Proven experience managing clinical trial submissions.
• Strong command of regulatory platforms and tools.

Responsabilidades

• Lead and coordinate regulatory activities for assigned products.
• Manage Product Information and ensure accurate implementation.
• Oversee clinical trial submissions in Spain.

Conocimientos

Regulatory Affairs

Product Lifecycle Management

Clinical Trial Submissions

Health Authority Engagement

Fluency in Spanish

Fluency in English

Herramientas

Veeva Vault

HA Portals

Artwork Systems

Descripción del empleo

Location : Madrid (Hybrid / Remote flexibility)

Client : Pharmaceutical Company (via Oxford Global Resources)

About the Role :

We are currently seeking a Global Regulatory Sciences Specialist to support client's regulatory activities across a broad portfolio of pharmaceutical products. This role offers the opportunity to work in a cross-functional and strategic environment, leading regulatory operations both at the national and European level. The position is ideal for a regulatory affairs professional with strong experience in product lifecycle management, clinical trial submissions, and health authority engagement .

Key Responsibilities :

• Lead and coordinate regulatory activities for assigned products, including Marketing Authorization Applications (MAA) , variations , renewals , withdrawals , and regulatory updates .
• Manage Product Information (SmPC, PIL, labelling) and ensure accurate implementation of final artwork through platforms like DigiCAM, GAME, and TVT.
• Maintain regulatory databases (e.g., Veeva , internal platforms, HA databases), and ensure proper archiving of documentation.
• Oversee clinical trial submissions in Spain (iCTAs, substantial amendments, DSURs, label approvals) in coordination with AEMPS and CAM .
• Support compassionate use / foreign medicine programs via AEMPS’ Medicines in Special Situations system.
• Monitor competitor regulatory procedures and updates from EMA, AEMPS, CMDh, HMA .
• Participate in shortages management , HA meetings, public tender responses, and IDMP implementation .
• Provide training to internal and external stakeholders on relevant regulatory topics.
• Support digital innovation in regulatory processes; contribute to tool development and digital communication initiatives.
• Collaborate with cross-functional teams (Marketing, Medical, Market Access) with a strategic mindset, including review and approval of promotional and non-promotional materials .

Key Skills & Requirements :

• Minimum 2-3 years of experience in Regulatory Affairs within the pharmaceutical industry, preferably with EU and Spanish regulatory expertise .
• Proven experience managing clinical trial submissions , product lifecycle regulatory procedures, and HA interactions .
• Strong command of regulatory platforms and tools (e.g., Veeva Vault, HA portals, artwork systems).
• Excellent knowledge of EMA, AEMPS, and EU regulatory frameworks.
• Proactive, well-organized, and able to work in cross-functional, international teams.
• Fluency in Spanish and English (written and spoken) is essential.
• Permanent contract via Oxford Global Resources
• Hibrid 40% home-based
• Medical Insurance
• Salary range : 39.000-42.000

Interested in this role?

Apply now or contact Oxford Global Resources to learn how you can join an impactful project supporting one of the world’s leading biopharma companies.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Research, Project Management, and Science

Pharmaceutical Manufacturing, Biotechnology Research, and Business Consulting and Services

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