Overall Responsibilities:

• Handles timely submission and follow-up of labeling & CMC variations and GMP submissions.
• Ensures permanent compliance to local regulatory requirements and to Organon’s policies and procedures.
• Demonstrates clear leadership in shaping the regulatory environment to support company objectives.
• Keeps abreast on regulatory environment evolution and challenges, provides advice on resulting strategy.
• Ensures that local Quality activities are completed according to company Quality Systems and all legal requirements are met.

Skills Required:

• Bachelor’s Degree in Pharmacy (preferred), Chemistry, Chemical Engineering
• Minimum 2 years of experience in Regulatory Affairs in similar position
• English Fluency
• Leadership competencies
• Strategic thinking and proactive management capability
• Collaboration and active communication
• High sense of customer orientation
• High sense of collaboration
• Advanced negotiation skills