Regulatory Affairs Specialist role at Merck in Madrid, Spain, focused on managing the regulatory lifecycle for oncology and vaccine products. The position involves coordinating Marketing Authorization applications, maintaining product compliance, and engaging with Spanish and European health authorities to ensure timely patient access to therapies.
Responsibilities
- Prepare, submit, and follow up on Marketing Authorization applications to AEMPS and EMA with cross-functional coordination
- Maintain assigned authorized products in regulatory compliance through variations and renewal submissions
- Manage labelling translation and lifecycle maintenance for SmPCs, Package Leaflets, and packaging materials
- Monitor regulatory intelligence and legislation updates in Spain and EU, informing internal stakeholders
- Foster relationships with internal and external partners including health authorities and cross-functional teams
Requirements
- Bachelor's degree in Pharmacy or Life Sciences; Master's in Regulatory Affairs or related field preferred
- 1–2 years of pharmaceutical industry experience, preferably in regulatory affairs
- Solid knowledge of pharmaceutical legislation and regulatory procedures in Spain and EU
- Professional proficiency in Spanish and English with strong communication skills
- Strong organizational, planning, and prioritization skills with attention to detail
- Ability to work independently and collaboratively in multidisciplinary teams under pressure
- Proficiency in digital workplace technologies and demonstrated AI literacy
📌 Specialist, Regulatory Affairs (España)
🏢 Merck
📍 España