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Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.
For their office in Bern we are looking for a 8-month contract (hybrid) for a:
Global Regulatory Affairs CMC Manager- 5505 LBD
- Responsible for operational regulatory CMC activities:
- Coordination, preparation and review of regulatory submission packages related to CMC submissions and Health Authority responses for the Gene Therapy portfolio.
- Supports scheduling and prioritization of CMC related submissions.
- Responsible for the compilation and maintenance of CMC documentation/CTD for regulatory submissions and cooperation with relevant technical expert departments in cross-functional teams.
- Responsible for regulatory CMC documents/CTD documentation formatting and maintenance within document management system, maintenance of relevant regulatory lists and tracking documents.
- Provision or support of timely and compliant regulatory assessments as well as efficient execution of CMC changes.
- Evaluates available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks.
- Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- BSc or MSc. degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
- Minimum 2 years experience in CMC regulatory in the pharmaceutical industry, additional experience in Gene Therapy preferred.
- Experience in new registrations and life-cycle management for different markets including US, EU, CH, CA, AU, JP.
- Good knowledge of laws, regulations, and guidance governing biologics and Cell and Gene Therapy (CGT) / Advanced Therapy Medicinal Products (ATMPs).
- Excellent communication, project management, planning, problem solving and presentation skills.
- Strong Team player and organizational follow-up skills, as well as attention to detail.
- Flexibility to work in a global cross-cultural work environment.
- Microsoft Office skills and document management systems (CTC module 3, Veeva Vault) and quick learning of new systems to be used during operational work.
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