Specialist, Regulatory Affairs

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

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, please apply today.

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

Flexible Work Arrangements: Hybrid

Shift: Valid Driving