Specialist, Regulatory Affairs
Core
Manage the regulatory lifecycle for Oncology and Vaccines product portfolios in Spain, ensuring compliant patient access through interactions with health authorities.
Role type
Specialist Regulatory Affairs (Pharmaceuticals)
Builds
Marketing Authorization applications, variations, renewals, and lifecycle documentation for authorized products.
Domain
Pharmaceuticals, Oncology, Vaccines, European and Spanish regulatory compliance
Required skills
Pharmaceutical legislation knowledge, Regulatory procedures, Spanish and English proficiency, Document management, Digital workplace technologies, AI literacy
Preferred skills
Master's degree in Regulatory Affairs/Biotechnology, Experience with EMA submissions, Pharmacovigilance collaboration
Technologies
Document management systems, Databases, Collaboration platforms, Enterprise-approved AI tools
Responsibilities
Prepare and submit Marketing Authorization applications to AEMPS and EMA; Maintain compliance for authorized products via variations and renewals; Manage labelling translation and lifecycle maintenance for SmPCs and packaging; Monitor regulatory intelligence and legislation updates; Support cross-functional compliance activities (PSUR, aRMM); Develop and maintain local SOPs.
Seniority
Junior to Mid-level, hands-on IC