Regulatory Affairs Specialist: Oncology & Vaccines (Spain)

MSD

España

Hybrid

GBP 35,000 - 53,000

Full time

4 days ago

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Benefits offered by this job

Hybrid work model

Job summary

MSD in Spain is seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team, driving lifecycle management for Oncology and Vaccines. You will work with local, regional, and global partners and engage with authorities such as AEMPS to ensure compliant and timely patient access to innovative therapies.

The ideal candidate has a Life Sciences degree, 1–2 years in pharma regulatory affairs, fluent Spanish and English, and strong organizational skills.

Qualifications

Bachelor in Pharmacy or life sciences; Master’s preferred.
1–2 years in pharma regulatory affairs.
Solid knowledge of EU/Spanish regulatory guidelines.
Fluent in Spanish and English.
Strong organization and time-management skills.
Proficient with digital tools and AI-enabled productivity tools.

Responsibilities

Prepare and submit regulatory applications to AEMPS/EMA and coordinate cross-functional teams.
Maintain products with variations and renewals to ensure compliance.
Oversee labeling translations and SmPC lifecycle maintenance.
Monitor regulatory intelligence in Spain and EU and inform stakeholders.
Foster relationships with internal teams and Health Authorities.
Support PSUR/aRMM submissions and SOP maintenance.