Global Regulatory Affairs Professional for CMC
Vor 3 Tagen
Expand your expertise in global regulatory quality requirements as a Regulatory Affairs Manager (CMC)
About the RoleWe seek an experienced professional to support the approval and maintenance of medicinal products, ensuring compliance with global regulatory standards.
Your Key Responsibilities:
- Create, review, and update high-quality CMC documentation to obtain and maintain product approvals.
- Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status.
- Handle and manage inquiries related to quality documentation from authorities.
- Oversee regulatory CMC projects, communicate with stakeholders, and coordinate third-party services.
- Develop regulatory CMC strategies and represent regulatory requirements in project teams.
- Maintain a detailed understanding of global and national CMC regulatory requirements and best practices.
About You
- Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field. A doctorate is an advantage.
- 3-5 years of experience in regulatory affairs or a department responsible for CMC matters.
- Strong communication skills, including profound English.
- Analytical and systemic thinking.
- Strong negotiation skills and teamwork.
- Solution-oriented with a focus on compliance and quality.
Welcome to Merz Therapeutics, a leading pharmaceutical company dedicated to improving treatment outcomes for patients worldwide.
We are a family-owned company committed to serving our patients' needs for 110 years and have become a global innovation leader with products in over 90 countries.
Our goal is to use our products to improve treatment outcomes for patients, thereby reducing the burden of suffering for affected individuals and their surroundings.
We strive to identify unmet patient needs through relentless research and development and provide appropriate treatments.
Become part of our international and motivated team at Merz Therapeutics and help us achieve our goal: Better Outcomes for More Patients.
Estimated Salary: €60,000 - €80,000 per annum, depending on experience and qualifications.
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