Jobbeschreibung

Positionsnummer / Reference Number

PA1202102092020

Position / Job Title

Senior Regulatory Affairs Manager

Aufgaben / Tasks

- Responsible for the regulatory affairs activities in EU, CH and ROW
- Indication Oncology / Hematology
- Responsible leading a small team (3 direct reports), based in Basel
- Definition and implementation of regulatory strategies to expand the portfolio and territories
- Preparation and submission of marketing authorization applications in Europe (DCP/MRP/ CP), Switzerland, and in other countries with support of local partners
- Life cycle management and maintenance of product approvals (renewals/variations/FUMs) worldwide
- Supervision of legal requirements and regulatory records to ensure proper traceability of regulatory history and of actual regulatory status
- Cooperation with other departments (internal and external stakeholders) to align timelines and regulatory strategies
- Participation and active contribution in meetings with partners and authorities

Qualifikationen / Qualifications

- University degree (PhD, MSc) in Life Sciences, Pharmaceutical or Medical Sciences
- Minimum of 5 years of experience in hands-on working in Regulatory Affairs in EU and preferably other regions
- Strong communication and negotiation skills
- Strategic thinking and solution-oriented work approach
- Experience in people management and development, leadership skills
- Team player with customer-oriented behavior
- Ability to coordinate and network with various stakeholders simultaneously
- Fluency in German and English in writing and speaking; French knowledge advantageous
- Experience in CMC writing advantageous
- Experience in market access and pricing advantageous
Good knowledge of MS-Office

Weitere Informationen / Further Information

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