International Regulatory Affairs Manager

vor 1 Tag

Basel, Schweiz Sobi Vollzeit

**Company Description**
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.

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

**Additional Information** 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 skills
- Ensure exemplary behaviour, ethics and transparency within the Company and with regulatory agencies
- In addition, you should live up to our core values: Ambition, Ownership, Urgency, Partnership and Care._

  • Associate Medical Affairs 100%

    vor 2 Wochen

    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 Wochen

    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 1 Woche

    Basel, Schweiz LHH Vollzeit

    Für unseren Mandanten, ein international agierendes Medizintechnikunternehmen, suchen wir für die Niederlassung im Grossraum Basel Verstärkung durch einen **Regulatory Affairs Manager (w/m/d)**. **Aufgabengebiet** - Zulassungsdokumentation für EU- und Nicht-EU-Länder erstellen und pflegen - Bereiten Sie die relevanten Dokumente für die Genehmigung vor...

  • Regulatory Affairs Project Manager

    vor 4 Wochen

    Basel, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...

  • Regulatory Affairs Project Manager

    vor 2 Wochen

    Basel, Schweiz Alira Health Vollzeit

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...

  • Regulatory Affairs Manager

    vor 2 Wochen

    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...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Basel, Schweiz KMP Management Consulting Vollzeit

    **Eine spannende Herausforderung mit interessanten Perspektiven** Unser Mandant ist ein erfolgreiches, international agierendes Schweizer Familienunternehmen, welches sich auf die Entwicklung, die Produktion und den Vertrieb spezieller Medizinprodukte fokussiert hat. Die Unternehmung geniesst international eine hohe Reputation, entsprechend wächst die...

  • Regulatory Affairs Leader, EU Crop Protection

    vor 2 Wochen

    Basel, Schweiz Eurofins USA BioPharma Services Vollzeit

    An international life sciences company is seeking a professional to manage crop protection product registrations in Basel-Stadt. The ideal candidate will have at least 5 years of experience in regulatory affairs, particularly with EU crop protection regulations. Responsibilities include managing dossiers, coordinating with project teams, and fostering...

  • Regulatory Affairs Associate

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz nemensis ag Schweiz Vollzeit

    Regulatory Affairs Associate (m/w/d) 100%Make Your Mark in Global Pharmaceutical Regulatory AffairsDuration : 2 years (temporary)Location : BaselType : Temporary positionSalary : CHF 60.00 / h to CHF 72.00/hAbout Our ClientFor our client, a leading global pharmaceutical company based in Basel's renowned BioValley region, we are seeking a dedicated...

  • Director Regulatory Affairs, Emea

    Vor 5 Tagen

    Basel, Schweiz Cochlear Ltd Vollzeit

    Director Regulatory Affairs, EMEA **Job no**: 615328 **Work type**: Permanent **Location**: Basel **Categories**: Quality & Regulatory, Western Europe, People Manager **About Us** Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the...