Project Management
Posted on :
03-08-2024
Employer Active
1 Vacancy
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Job Description
Accountabilities:
As a CMC RA Manager, you will manage the timely preparation and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout their lifecycle. You will be accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders, ensuring submission quality. You will also develop expertise in regional regulatory requirements to ensure compliance of CMC submissions. Your role will involve project management, change management, and application of appropriate risk management across your activities.
Essential Skills/Experience:
- University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
- Minimum 8 years of relevant experience from biopharmaceutical industry.
- Breadth of knowledge of manufacturing, project, technical and regulatory management.
- IT Skills.
- Stakeholder & Project management.
- Professional capabilities: Regulatory knowledge.
- Desirable Skills
- Knowledge of the drug development process and regulatory submissions.
- Understanding of current regulatory CMC requirements.
- Direct/indirect Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products.
- Understanding of regulations and guidance governing the manufacture of biotechnology products.
- Lean capabilities.
Employment Type
Full-time
Department / Functional Area
Key Skills
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