Regulatory Affairs Manager (España)

Key Responsibilities

• Lead the regulatory team of 2 Regulatory Associates
• Manage registration procedures to obtain registrations for generic medicines in line with local legislation
• Maintain existing registrations (variations and renewals) and regulatory databases
• Translate SPCs, leaflets and labelling from English to Spanish and vice versa
• Review approved product information in the post‑registration/production phase
• Plan, coordinate and supervise all activities needed for obtaining marketing authorizations
• Communicate with local authorities and monitor local pharmaceutical legislation and the practice and trends of the Spanish medicine agency
• Work closely with Regulatory Affairs, Pharmacovigilance and QA headquarters and report to them

Qualifications

• University degree in Pharmaceutical Sciences, Chemistry, Medicine, Veterinary Medicine or Biology
• Minimum 3 years of ex...