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Regulatory Compliance Specialist
12 hours ago
We are looking for a Regulatory Affairs Manager who can lead our efforts in regulatory strategy development, policy monitoring, and cross-functional collaboration. The successful candidate will have a strong background in regulatory affairs and excellent communication skills.
The role reports to the Head of Regulatory Affairs, Quality Assurance, and Pharmacovigilance and is responsible for ensuring that the company's operations comply with relevant regulations. This includes developing and implementing policies and procedures to ensure compliance and providing training to employees on regulatory requirements.
Main Responsibilities:
- Regulatory Strategy Development: Supports the organization with regulatory strategic knowledge and assists with the development of standards for the company's operating procedures.
- Policy Monitoring: Keeps up to date with relevant regulations and provides recommendations to the leadership team.
- Cross-functional Collaboration: Supports and ensures review and management of internal approval of marketing material from a regulatory point of view.
- Communication with External Partners: Main contact for partner companies and competent authorities in matters of regulatory for both medicinal products and medical devices.
Qualifications & Skills:
- MSc of Pharmacy or other relevant degree in natural sciences
- Minimum 2 years of experience from Regulatory Affairs
- 2-5 years' experience within marketing compliance
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