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

Qualification & Skills:

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