Regulatory Affairs Specialist

Regulatory Affairs Specialist to manage regulatory activities for SPC medicinal products for human use, including obtaining and maintaining marketing authorizations in the European Union and supporting regulatory activities in various non-EU regions.

Requirements

• Scientific Degree
• Master in Regulatory Affairs (preferred)
• More than 5 years of experience in Regulatory Affairs within multinational pharmaceutical firms or international regulatory consulting companies
• Experience with the EU Centralised and Decentralised Procedures
• Background in OTC product development and lifecycle management
• High level of autonomy in managing assigned activities

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance