Regulatory Affairs Specialist
4 days ago
Proclinical Staffing is a leading life sciences recruiter focused on finding exceptional professionals and matching them with the finest positions across the globe.
Job Summary:
We are seeking a highly skilled Regulatory Affairs Manager to provide strategic regulatory leadership and support product launches in Central Eastern Europe and the Middle East.
About the Role:
This role involves close collaboration with supply chain, quality assurance, and commercial/medical teams to ensure compliance with country-specific regulatory requirements and manage potential risks. You will be responsible for providing strategic regulatory leadership to support product launches, collaborating with supply chain and quality assurance to identify regulatory requirements and risks, and supporting obtaining special import licenses and packaging waivers.
Main Responsibilities:
- Strategic Regulatory Leadership: Provide guidance and direction to cross-functional teams to ensure compliance with regulatory requirements and minimize risks.
- Collaboration and Communication: Work closely with supply chain, quality assurance, and commercial/medical teams to identify and mitigate regulatory risks.
- Regulatory Submissions: Prepare and deliver regulatory submissions throughout the product lifecycle, ensuring accuracy and completeness.
- Risk Management: Identify and mitigate potential risks associated with product launches, working closely with cross-functional teams.
- Regulatory Due Diligence: Conduct thorough assessments of business development opportunities to ensure compliance with regulatory requirements.
- Regulatory Review: Lead regulatory review of commercial and medical materials, ensuring accuracy and compliance.
Requirements:
- Degree in Science or Related Discipline: Hold a degree in science or another related discipline, such as law or biology.
- Regulatory Knowledge: Possess in-depth knowledge of European regulatory requirements for innovative products, including product registration in the Middle East.
- Analytical and Problem-Solving Skills: Demonstrate strong analytical, problem-solving, and communication skills, with the ability to work independently and as part of a team.
- Results-Focused: Be results-driven and able to meet deadlines, with a focus on delivering high-quality outcomes.
- Adaptable and Self-Motivated: Be adaptable, self-motivated, and able to prioritize effectively, with a willingness to learn and grow in a dynamic environment.
Estimated Salary: $80,000 - $110,000 per annum, depending on experience.
Benefits:
- Competitive Salary: Receive a competitive salary, commensurate with experience.
- Benefits Package: Enjoy a comprehensive benefits package, including health insurance, retirement savings, and paid time off.
- Opportunities for Growth: Take advantage of opportunities for career growth and professional development, working with a leading life sciences recruiter.
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