Manager, Regulatory Affairs, International

Vor 6 Tagen

Basel, Schweiz Sobi Vollzeit

**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.**

**Manager, Regulatory Affairs, International**:
**Role & Function**
One of Sobi’s four strategic pillars is to “Go Global”. The Manager, Regulatory Affairs International supports our ambitious geographical expansion plans. Sobi is seeking to register some of our existing portfolio into new territories and to register several of our development projects into the international region. This role is key to driving both the Regulatory strategy and execution.

**Key Responsibilities**
- Represent International region in Global Regulatory Team and other cross-functional forums, for assigned products- Develop International regulatory strategies and filing plans, in partnership with the Global Regulatory Lead, and country leads, for assigned products in development- Plan and create a core dossier for International, in partnership with cross-functional teams, for assigned products- Develop regulatory strategies in assigned countries, in partnership with local Regulatory teams-
- Provide strategic guidance on regulations and changes in assigned countries- Support interactions with Health Authorities in assigned countries**Qualifications**
- A University Degree in Life Sciences is required with 5 to 7 years of industry experience, of which at least 3 years of experience within Regulatory Affairs (registration, development, maintenance)- Experience of regulatory requirements in countries outside the US and Europe- Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset- Experience from leading projects and cross-functional teams**Personal attributes**

**Location**
The position will be based in Basel, Switzerland.

**Reporting to**
Director, Regulatory Affairs, International

**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

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