Ra Cmc Manager
vor 1 Woche
A Regulatory Affairs CMC Manager is required to join a global pharmaceutical company based in Basel on an 18-month contract.
What you will be doing:
- Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stake holders.
- Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate
What you can bring to the role:
- University Degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or equivalent.
- Working knowledge/experience in regulatory submission and approval processes desirable.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the product development and life cycle desirable.
- Demonstrated track record to successfully work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload
- Fluency in English
What you get in return:
- A longterm contract position
- The opportunity to work with a global pharmaceutical giant
- Competitive hourly rates
What to do next:
Salary:
CHF CHF72.00 per hour
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Basel, BS: Reliably commute or planning to relocate before starting work (required)
Work Location:
One location
Expected Start Date: 10/01/2023
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