International Regulatory Affairs Manager

vor 7 Monaten

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._

  • Manager, Regulatory Affairs, International

    vor 1 Woche

    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...

  • International Regulatory Affairs Intern

    vor 7 Monaten

    Basel, Schweiz Mirum Pharmaceuticals Vollzeit

    **MISSION**: **Job Summary**: As an Intern in Regulatory Affairs International team, you will work closely with the regulatory affairs team to ensure compliance with applicable regulations, standards, and guidelines governing the development, manufacturing, and marketing of pharmaceutical products. This entry-level position provides an excellent opportunity...

  • Regulatory Affairs Manager

    vor 2 Monaten

    Basel, Schweiz Boehringer Ingelheim (Schweiz) GmbH Vollzeit

    Innovative Medikamente für Mensch und Tier: Dafür steht das forschungsbasierte Pharmaunternehmen Boehringer Ingelheim seit über 130 Jahren. Boehringer Ingelheim zählt zu den 20 führenden Unternehmen der Branche und ist auch heute noch ein Familienunternehmen. Jeden Tag schaffen rund 52.000 Mitarbeiter Werte durch Innovation in den drei...

  • Regulatory Affairs Consultant

    vor 1 Woche

    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 Manager

    vor 2 Wochen

    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. -...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Basel, Schweiz Spring Professional Vollzeit

    Für unseren Kunden mit Firmensitz im Grossraum Basel - ein innovatives, global vernetztes, pharmazeutisches Unternehmen, mit über 25 Jahren Erfahrung - suchen wir zum nächstmöglichen Zeitpunkt einen Regulatory Affairs Manager (m/w/d). Ein familiärer Umgang, flache Hierarchien sowie eine täglich gelebte Wertschätzung zeichnen unseren Kunden aus. Haben...

  • Drug Regulatory Affairs Manager

    vor 1 Woche

    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...

  • Regulatory Affairs Manager

    vor 20 Stunden

    Basel, Schweiz BÜHLMANN Laboratories AG Vollzeit

    **BÜHLMANN Laboratories AG **ist eine international tätige und innovative Produktions - und Handelsfirma im Bereich Life Sciences. Das Unternehmen mit Hauptsitz in Schönenbuch beschäftigt mehr als 120 Mitarbeitende und ist global aktiv. Die selbst entwickelten und hergestellten diagnostischen Kits und Reagenzien werden weltweit als **in vitro...

  • Regulatory Affairs Manager

    Vor 2 Tagen

    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...

  • Junior Regulatory Affairs Manager

    vor 2 Wochen

    Basel, Schweiz Spring Professional Vollzeit

    Unser Kunde, ein aufstrebendes und internationales Pharmaunternehmen aus dem Raum Basel, sucht zum nächstmöglichen Zeitpunkt einen Junior Regulatory Affairs Manager (m/w/d). Das Unternehmen hat sich auf die Produktion von Arzneimittel spezialisiert. Möchten Sie auch Teil des Unternehmenserfolgs werden? Zögern Sie nicht und senden Sie uns Ihre...

  • International Regulatory Affairs Manager

    vor 4 Monaten

    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 Project Manager

    vor 3 Monaten

    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 PROJECT MANAGER

    Vor 2 Tagen

    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

    vor 1 Woche

    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...

  • Regulatory Affairs Manager

    vor 20 Stunden

    Basel, Schweiz Lonza Vollzeit

    Switzerland, Basel - Switzerland, Visp**Randstad Inhouse Services** is looking for a Regulatory Affairs Manager (M/F/d) for **Lonza AG** in Basel (100%). This is a **temporary **position for 12 months with an opportunity for an extension. Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science,...

  • Regulatory Affairs Manager für Pharma- und Healthcare-Projekte

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit

    BerufsbildWir suchen einen erfahrenen Regulatory Affairs Manager, der unser Team in Basel als Senior Regulatory Affairs Consultant verstärkt. In dieser Schlüsselrolle gestalten Sie die Geschäfts-, Portfolio- und Marktentwicklung aktiv mit.Ihre Aufgaben:Vielfalt trifft Verantwortung: Betreuung von RA-Projekten für internationale Kunden, Entwicklung und...

  • Global Regulatory Affairs Manager

    vor 2 Wochen

    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...

  • Principal Advisory Consultant in Regulatory Affairs

    vor 1 Woche

    Basel, Schweiz NNIT Vollzeit

    _Use your experience to digitally transform Regulatory Affairs and Safety_! NNIT is looking for a principal consultant with deep Regulatory Affairs expertise who wishes to make a mark on some of the most exciting digital projects in the Life Sciences industry. The NNIT Regulatory Affairs Advisory team is at the forefront of supporting global pharmaceutical...

  • Manager, Regulatory Affairs Emea

    vor 7 Monaten

    Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit

    **Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...

  • Regulatory Affairs Project Manager

    vor 1 Woche

    Basel, Schweiz NonStop Consulting Vollzeit

    My client is offering an amazing opportunity to work on site in Basel for 7 months as a Regulatory Affairs Project 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. **Requirements**: 3+ years Regulatory experience in a...