Specialist, Regulatory Affairs

1194 MSD de España, S.A.; 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

Job Description An amazing opportunity has arisen for a Regulatory Affairs Specialist to join our Regulatory Affairs team in Spain. In this role, you will be part of an experienced and talented team responsible for the regulatory lifecycle management of our assigned product portfolio in Spain, with a dedicated focus on the therapeutic areas of Oncology and Vaccines, as well as participating in strategic special projects. Reporting directly to the Regulatory Affairs Director, you will collaborate closely with internal stakeholders across local, regional, and global levels, while actively engaging with external health authorities such as the Spanish Medicines Agency (AEMPS) to ensure compliant and timely patient access to innovative therapies.

What you will do:

• Ensure timely preparation, submission, and thorough follow-up of new Marketing Authorization applications to the AEMPS and, as applicable, the EMA, coordinating with local, regional, and global cross-functional teams.
• Maintain assigned authorized products in full regulatory compliance through the timely preparation and submission of variations and renewal applications.
• Ensure high-quality labelling translation and lifecycle maintenance for local Summary of Product Characteristics (SmPCs), Package Leaflets, packaging materials, and artwork management in alignment with European and Spanish guidance and internal IT systems.
• Monitor, collect, and assess publicly available regulatory intelligence and legislation updates in Spain and the EU, keeping internal stakeholders proactively informed.
• Foster and sustain positive relationships with internal and external partners, including Pharmacovigilance, Medical Affairs, Marketing Access, In-Market Quality, Manufacturing, Customer Service, and Health Authorities.
• Support regulatory-related cross-functional compliance activities, including PSUR and aRMM submissions, while participating in the development and maintenance of local Standard Operating Procedures (SOPs).

What skills you will need:

• A Bachelor of Science (B.Sc.) degree in Pharmacy or another Life Sciences discipline; a Master’s degree in Regulatory Affairs, Biotechnology, or a related Life Sciences field is preferred.
• A minimum of 1–2 years of experience in the pharmaceutical industry, preferably in a regulatory affairs function.
• Solid working knowledge of pharmaceutical legislation, regulatory procedures, and guidelines applicable in Spain and the European Union.
• Professional proficiency in both Spanish and English, with strong verbal and written communication skills.
• Strong organizational, planning, and prioritization skills, with meticulous attention to detail.
• Proven agility and flexibility to handle conflicting time pressures and navigate a demanding workload effectively.
• Demonstrated ability to work independently with initiative while collaborating effectively within a multidisciplinary team.
• Proficiency in digital workplace technologies, including document management, databases, and collaboration platforms.
• Demonstrated digital and AI literacy, including the responsible and effective use of enterprise-approved AI-enabled and productivity tools.

Why Join Us?

As a company, we are committed to keeping the patient at the very heart of all that we do and striving to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to make an impact,

Additional location(s) Compensation Information:

Required Skills: Artificial Intelligence (AI), Life Science, Pharmaceutical Industry, Pharmaceutical Regulatory Affairs, Pharmacy Laws, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/21/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.