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.

Senior Global Regulatory Affairs Manager

Role & Function

In order to support our business, the Global Regulatory Affairs (GRA) department is looking for a Senior Global Regulatory Affairs Manager to join the growth journey. We have several development projects in our portfolio as well as marketed products to be supported. In parallel, we are expanding into new markets with our products.

Key Responsibilities

• Represent Regulatory Affairs in external meetings such as Scientific Advice


• Participate in strategic and regulatory evaluations of in-licensing matters


• Coordinate and submit applications to the regulatory authorities


• Is an expert on processes, applications and regulatory environment to achieve and maintain marketing authorizations


• Provide regulatory strategies


• Influence the content of regulatory applications


• Is a regulatory representative in the Project/Product Teams


• Cooperate with authorities, partners, regulatory consultants and other departments within Sobi

Personal attributes

- A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds- Highly self-motivated and able to drive activities- Excellent communication skillsThe suitable candidate should demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership

Qualifications

• A University Degree in Life Sciences is required with 10 years of progressively relevant work experience, of which at least 6 years of experience from pharmaceutical industry, competent authority or regulatory consultancy services (registration, development, maintenance)


• Experience of regulatory requirements in the EU / US and outside is an advantage for roles working with geographic expansion.


• Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset.


• Experience from leading teams and collaborations is a strong advantage

Location

The position will be based in , Switzerland.

Reporting to

The Global Regulatory Affairs Lead

Recruitment contact & how to apply

Sobi

www.sobi.com

Position

Senior Global Regulatory Affairs Manager

Function

Regulatory Affairs

Location

Switzerland

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