Head of Regulatory Affairs – Croatia & Slovenia... @ PharmaS
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About the Role
The Head of Regulatory Affairs – Croatia & Slovenia In-Licensed Products at PharmaS will lead regulatory activities in Croatia and Slovenia, manage regulatory submissions, approvals, and ensure compliance with local and EU legislation. This role includes coordinating regulatory strategy for In-Licensed products and acting as the primary contact with health authorities and external stakeholders.
Key Responsibilities
- Lead and oversee regulatory activities for Croatia and Slovenia.
- Manage regulatory submissions and approvals including new MAs, renewals, and labeling updates.
- Ensure compliance with local laws, EU legislation, and company standards.
- Act as the primary regulatory contact with health authorities and external stakeholders.
- Coordinate regulatory strategy and execution for In-Licensed products in EU and Non-EU markets.
- Provide regulatory input to cross-functional teams to support product launches and lifecycle management.
- Monitor regulatory developments and assess their business impact.
- Contribute to process optimization, standardization, and knowledge sharing within the Regulatory Affairs function.
- Represent the RA function in internal and external meetings.
Qualifications & Experience
A university degree in Pharmacy, Medicine, Life Sciences, or a related field (Pharmacy degree preferred) is required. A minimum of 7 years experience in Regulatory Affairs, with significant exposure to EU markets, is essential. Proven expertise in managing submissions and interactions with local authorities and familiarity with In-Licensed products is an advantage. Strong organizational, project management, communication, negotiation, and leadership skills are a must. Proficiency in English is required.
What We Offer
This is a dynamic role with regional responsibilities and an opportunity to lead regulatory strategy for both local markets and In-Licensed products. PharmaS offers a collaborative international work environment, competitive compensation and benefits, and professional development opportunities.
Key skills/competency
- Regulatory
- Compliance
- Submissions
- Approvals
- Strategy
- EU Legislation
- In-Licensed
- Leadership
- Project Management
- Stakeholder Engagement
How to Get Hired at PharmaS
🎯 Tips for Getting Hired
- Research PharmaS culture: Understand their mission, growth, and values.
- Customize your resume: Highlight Regulatory Affairs experience and EU expertise.
- Showcase leadership: Emphasize managing submissions and teams.
- Prepare regulatory examples: Detail strategic compliance achievements.