Specialist, Regulatory Affairs

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:

Bring energy, knowledge, innovation and leadership to carry out the following:

• 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:

In order to excel in this role, you will more than likely have:

• 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.

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

Preferred Skills

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Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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