Regulatory Affairs Specialist – Oncology & Vaccines (Hybrid)

MSD; Madrid; Hybrid; EUR 42,000 - 65,000; Full time

Job summary

MSD in Spain is seeking a Regulatory Affairs Specialist to manage regulatory lifecycle for oncology and vaccines portfolios. You will coordinate with local, regional and global teams and engage with AEMPS to ensure timely access to innovative therapies.

You will prepare MA applications, manage variations and renewals, and ensure labeling and SmPCs comply with EU and Spanish guidance. Strong Spanish/English skills and 1–2 years of experience are required.

Qualifications

• Bachelor of Science in Pharmacy or life sciences; master preferred.
• 1–2 years of pharmaceutical regulatory experience.
• Fluency in Spanish and English with strong communication skills.

Responsibilities

• Prepare and submit regulatory applications to AEMPS and EMA as applicable.
• Maintain compliant products via variations and renewals.
• Translate and manage SmPCs, leaflets, packaging, and artwork.
• Monitor regulatory intelligence in Spain and the EU and inform stakeholders.
• Collaborate with Pharmacovigilance, Medical Affairs, Marketing Access and Health Authorities.

Skills

Regulatory affairs knowledge

Bilingual Spanish/English

Regulatory documentation

Education

BSc Pharmacy or Life Sciences

Master's in Regulatory Affairs or related

Tools

Document management systems

Regulatory databases

Job description

MSD in Spain is seeking a Regulatory Affairs Specialist to manage regulatory lifecycle for oncology and vaccines portfolios. You will coordinate with local, regional and global teams and engage with AEMPS to ensure timely access to innovative therapies.

You will prepare MA applications, manage variations and renewals, and ensure labeling and SmPCs comply with EU and Spanish guidance. Strong Spanish/English skills and 1–2 years of experience are required.