Manager, Regulatory Affairs, International

Vor 5 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.

  • Associate Medical Affairs 100%

    Vor 2 Tagen

    Basel, Schweiz SFL Regulatory Affairs & Scientific Communication Vollzeit

    Would you like to join and contribute to an award-winning, successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients...

  • Associate Public Affairs 100%

    Vor 2 Tagen

    Basel, Schweiz SFL Regulatory Affairs & Scientific Communication Vollzeit

    Would you like to join and contribute to an award-winning, successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients...

  • Regulatory Affairs Manager

    Vor 7 Tagen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are working alongside a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis. The opening position is for a Regulatory Affairs Manager. For more information, please get in touch now! **Responsibilities**: - Conduct regulatory evaluations for aberrations and change control. -...

  • Drug Regulatory Affairs Manager

    Vor 5 Tagen

    Basel, Schweiz NonStop Consulting Vollzeit

    My client is offering an amazing opportunity to work on site in Basel for 18 months as a Drug Regulatory Affairs Manager. During your time in this role you will also have the opportunity of growth and promotion giving you the possibility of earning even more money over the period of the contract. If this sounds like it is something for you click below and...

  • International Regulatory Affairs Manager

    Vor 4 Tagen

    Basel, Schweiz Sobi Vollzeit

    **Company Description** **_ At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Here at Sobi, our mission and culture get...

  • Regulatory Affairs Consultant

    Vor 5 Tagen

    Basel, Schweiz NNIT Vollzeit

    **Regulatory Affairs Consultant** - Use your pharmaceutical experience to transform Regulatory Affairs_ NNIT is looking for Consultants with a deep pharmaceutical expertise and regulatory insight keen on making a mark on some of the most exciting digital transformations projects within the Life Sciences industry. The NNIT Life Sciences Consulting team is at...

  • Regulatory Affairs

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Michael Page Vollzeit

    Globally operating pharmaceutical companyTemporary assignment for 12-24 monthsAbout Our ClientFor our client, a globally renowned pharmaceutical company in the Basel area, we are seeking a Regulatory Affairs CMC professional to strengthen the team in 2026 in support of Phase 3 development activities. The contract duration is 12-24 months and is open to...

  • Regulatory Affairs

    Vor 5 Tagen

    Basel, Schweiz LGT Vollzeit

    Die LGT ist die weltweit grösste Private Banking und Asset Management Gruppe im Besitz einer Unternehmerfamilie. Als Family Office des Fürstenhauses von Liechtenstein überzeugen wir Sie mit langjähriger Erfahrung in der Verwaltung grosser Vermögen. Stellenbeschreibung Für unsere langfristige Weiterentwicklung im Intermediär-Geschäft übernehmen Sie...

  • Global Regulatory Affairs Manager

    vor 1 Woche

    Basel, Schweiz EDP Personalberatung Vollzeit

    **#Pharma #RegulatoryAffairs***: Our customer, a **pharmaceutical company based near Basel**, needs reinforcement. For a **temporary employment** **, **we are looking for a **Global Regulatory Affairs Manager (M/F/d), 100%**: **Jetzt bewerben** **Major accountabilities**: - Lead the joint efforts for the development of the global product approval...

  • Regulatory Affairs Manager

    Vor 2 Tagen

    Basel, Schweiz unisite AG Vollzeit

    Die Gesundheit und die Lebensqualität von Patienten zu verbessern, ist das Ziel des forschenden Pharmaunternehmens Boehringer Ingelheim. Seit der Gründung im Jahre 1885 in Familienbesitz, zählt Boehringer Ingelheim zu den 20 führenden Unternehmen der Branche. Für die drei Geschäftsbereiche Humanpharmazeutika, Tiergesundheit und Biopharmazeutika...