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.

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).

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.

Current Employees apply HERE

Current Contingent Workers apply HERE