Regulatory Affairs Specialist
20 hours ago
About the Role:
We're seeking an experienced Regulatory Affairs Specialist to provide regulatory leadership, governance, and expertise to support the labelling of existing products globally. As a key member of our team, you will build collaborative relationships with Global and Regional Regulatory Affairs to ensure accurate product information for healthcare professionals, patients, and consumers.
Key Responsibilities:
- Develop high-quality regulatory files supporting local submissions.
- Prepare responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders.
- Ensure compliance with established processes, policies, SOPs, and working instructions.
Requirements:
- Bachelor's degree in Life Science or Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering).
- Excellent communication and interpersonal skills.
- Ability to work collaboratively as part of a global team.
Salary Estimate:
$95,000 - $115,000 per year, depending on experience and location.
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