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Job Description
We are looking for an experienced and highly competent Head of Medical Regulatory Affairs to lead the department, organising our team and operations internally while dealing expertly with our global customers and relevant authorities.
Job Responsibilities:
- Provide general direction, tactical objectives, and functional plans for execution.
- Daily follow-up and coordination with team, customers and authorities to ensure smooth running of operations.
- Assume responsibility for performance of team members.
- Set processes and KPIs and ensure they are being met.
- Report on department performance to management.
- Act as an in-house regulatory expert, advising and supporting logistics teams.
- Manage and monitor product registration of medical, cosmetics and nutrition products with relevant authorities.
- Manage and monitor preparation, submission and review of regulatory documentation in collaboration with logistics teams.
- Manage business relationship with customers.
- Maintain solid relationships with authorities (CAPA, EDA, NODCAR, NFSA, etc.)
Job Requirements
- 5-8 years of proven experience in Regulatory Affairs, especially Medical/Health Care
- Ability to prioritise, multi-task and work well under pressure to meet deadlines.
- Clear and systematic thinking that demonstrates strong judgement and problem solving competencies.
- Excellent communication skills.
- Highly organised and structured.
- Solid strategic thinking and leadership abilities.
- Excellent management, negotiation and advocacy skills.
- Strong ability to interact with internal and external stakeholders.
- Proven experience of leading and motivating teams to achieve optimum performance
- Fluency in English
