
Head of Regulatory Affairs
1 week ago
For our client, a pharmaceutical company with a focus on licensing and distribution of medicines and medical products, we are looking for motivated candidates to join their team in the position of:
Head of Regulatory Affairs (Belgrade)
Job description
- Leading, mentoring, and developing the regulatory team, setting objectives, monitoring performance, and ensuring effective workload distribution
- Defining and implementing regulatory strategies for product registrations, renewals, variations, and other lifecycle management activities
- Monitoring and interpreting legislative changes in Serbia, Croatia, and additional markets, and ensuring timely alignment of internal processes
- Acting as the primary contact with regulatory authorities, coordinating communication during submissions, inspections, and audits
- Reviewing and approving promotional materials, labeling, and packaging to ensure compliance with regulatory requirements
- Overseeing the preparation, submission, and tracking of regulatory documentation and databases
- Identifying regulatory risks, resolving escalated or complex issues, and ensuring smooth operational execution.
Position requirements
- University degree in Pharmacy
- Minimum 5+ years of experience in regulatory affairs in senior roles
- Proven experience in leading and developing a team
- Fluency in written and spoken English
- Strong organizational and problem-solving skills
Candidate's profile:
- Strategic and analytical mindset
- High attention to detail
- Team-oriented leader with strong communication skills
- Adaptable and proactive in dynamic environments
Only shortlisted candidates will be contacted.
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