Head of Regulatory Affairs

1 week ago

Belgrade, Central Serbia Workforce Adriatic Full time €60,000 - €80,000 per year

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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