Regulatory Affairs Specialist – Oncology and Vaccines

About the role

MSD is looking for a Regulatory Affairs Specialist to join its Regulatory Affairs team in Spain, based in Madrid. You will help manage the regulatory lifecycle of the assigned product portfolio, with a focus on Oncology and Vaccines, and take part in strategic special projects. The role reports to the Regulatory Affairs Director and works closely with local, regional and global stakeholders, as well as with health authorities such as the Spanish Medicines Agency (AEMPS).

Key responsibilities

• Prepare, submit and follow up new Marketing Authorization applications to the AEMPS and, where applicable, the EMA, coordinating with local, regional and global teams.
• Keep authorized products in full regulatory compliance by preparing and submitting variations and renewal applications.
• Ensure high-quality labelling translations and lifecycle maintenance of local Summary of Product Characteristics (SmPCs), package leaflets, packaging materials and artwork, in line with European and Spanish guidance and internal IT systems.
• Monitor and assess regulatory intelligence and legislation updates in Spain and the EU and keep stakeholders informed.
• Maintain relationships with partners such as Pharmacovigilance, Medical Affairs, Marketing Access, In-Market Quality, Manufacturing, Customer Service and Health Authorities.
• Support regulatory compliance activities such as PSUR and aRMM submissions, and help develop and maintain local SOPs.

Required profile

• Bachelor's degree in Pharmacy or another Life Sciences discipline; a Master's in Regulatory Affairs, Biotechnology or a related field is preferred.
• At least 1-2 years of experience in the pharmaceutical industry, preferably in regulatory affairs.
• Professional proficiency in Spanish and English, with strong written and verbal communication.
• Ability to work independently and in a multidisciplinary team, with good organization and attention to detail.

Required skills

• Solid knowledge of pharmaceutical legislation, regulatory procedures and guidelines in Spain and the EU.
• Digital workplace tools: document management, databases and collaboration platforms.
• Digital and AI literacy, including the responsible use of enterprise-approved AI-enabled productivity tools.