Regulatory Affairs Specialist- Oncology & Vaccines (Hybrid)

Merck; Madrid; Hybrid; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck in Spain seeks a Regulatory Affairs Specialist to join our Regulatory Affairs team, focusing on Oncology and Vaccines. You will manage regulatory lifecycle for our product portfolio in Spain, collaborating with local, regional, and global teams, and engaging with health authorities to ensure timely patient access.

You will prepare and submit MA applications to AEMPS and EMA, maintain labeling and lifecycle updates, monitor regulatory intelligence, and support cross-functional compliance

Qualifications

• Bachelor-level life sciences or pharmacy degree; regulatory affairs exposure preferred.
• Regulatory knowledge of Spain/EU regulations; strong communication in Spanish and English.
• 1–2 years in pharma regulatory role; ability to work independently and manage deadlines.

Responsibilities

• Prepare submissions to AEMPS/EMA and coordinate with cross-functional teams.
• Maintain approved products with variations and renewals; ensure compliance.
• Oversee labeling, SmPCs, and packaging artwork per EU/Spain guidance.
• Monitor regulatory intelligence and inform stakeholders.
• Foster relationships with internal teams and Health Authorities; support SOPs.

Skills

AI literacy

Life sciences

Pharmaceutical industry

Regulatory affairs

Pharmacy laws

Regulatory compliance

Regulatory management

Regulatory experience

Bilingual Spanish/English

Digital tools

Education

B.Sc. in Pharmacy or Life Sciences

Master's in Regulatory Affairs or related

Tools

Document management systems

Databases

Collaboration platforms

Job description

Merck in Spain seeks a Regulatory Affairs Specialist to join our Regulatory Affairs team, focusing on Oncology and Vaccines. You will manage regulatory lifecycle for our product portfolio in Spain, collaborating with local, regional, and global teams, and engaging with health authorities to ensure timely patient access.

You will prepare and submit MA applications to AEMPS and EMA, maintain labeling and lifecycle updates, monitor regulatory intelligence, and support cross-functional compliance