Regulatory Affairs Manager (m/f/d) CMC
at Merz Therapeutics
6FAM, Hessen, Germany -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 16 Oct, 2024 | Not Specified | 17 Jul, 2024 | N/A | Regulatory Requirements,Project Teams,Change Control,Project Coordination | No | No |
Required Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
YOUR CONTRIBUTION
As a Regulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products. This will include the following activities:
CMC Documentation: Create, review, and update high-quality CMC documentation to obtain and maintain product approvals, ensuring compliance with global regulatory requirements; support the creation of IMPDs for clinical trial applications
- Change Control: Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status
- Response Management: Handle and manage inquiries related to quality documentation from authorities, ensuring timely and accurate responses
- Project Coordination: Oversee regulatory CMC projects, communicate with Merz representatives and partners, and coordinate third-party services
Regulatory Strategy: Develop regulatory CMC strategies and represent regulatory requirements in project teams and interdisciplinary teams
- Regulatory Intelligence: Maintain a detailed understanding of global and national CMC regulatory requirements and best practices
ABOUT US
Welcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.
We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.
Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.
Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.
Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: “BETTER OUTCOMES FOR MORE PATIENTS”
For more information, visit https://www.merztherapeutics.com/.
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Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
60438 Frankfurt am Main, Germany
