Regulatory Cmc Manager

Vor 3 Tagen

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**The Life Science Career Network**

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

We are currently looking for a role based in** Basel** for 18 months contract for a:
**Regulatory Affairs CMC Manager**

**Main Responsibilities**:

- 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;
- Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements;
- 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.

Qualifications and Experience:

- Relevant working/residency permit or Swiss/EU-Citizenship required;
- A Life Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent;
- 5 years + working knowledge and experience in regulatory submission and approval processes;
- Experience working in chemistry/biotechnology, analytics or pharmaceutical technology;
- Demonstrated track record to successfully work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.

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