Regulatory Affairs Professional

Regulatory Affairs Professional will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The holder of this position will organize regulatory information, track and control submissions and provide guidance and advice to internal stakeholder.

The Regulatory Affairs Professional will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The holder of this position will organize regulatory information, track and control submissions and provide guidance and advice to internal stakeholder.

Main Responsibilities & Tasks

• Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
• Provide expert regulatory input to strategic decision making; including review, prioritization, and external communications
• Support the development and establishment of policies and standards
• Coordinate successful submissions and approval of applications
• Plan, undertake and oversee regulatory inspections
• Liaise and negotiate with regulatory authorities
• Provide advice about regulations to relevant stakeholder
• Keep up-to-date with changes in regulatory legislation and guidelines
  
  

• Bachelor degree in a science or related field
• 5+ years relevant experience within the Regulatory Affairs discipline (Biotech Pharma, Device)
• Deep knowledge of the relevant Regulatory requirements
• Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations
• ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
• Proven analytical skill and technical/scientific competence
• Attention to details and ability to appropriately assess risks
• Strong initiation and organizational skills
• Excellent communication skills, with ability to influence others and negotiate successful outcomes
• Proactive, quick learner and independent worker able to effectively multi-task in a strongly growing organisation
• Team-player, able to positively influence Team members at all levels
• Fluent in English