Global Regulatory Affairs Lead

Vor 2 Tagen

München, Deutschland Sobi Vollzeit

Full-time

Sobi Location: Switzerland

**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 us excited to come to work every day, but here are a few more reasons to join our team:

- Competitive compensation for your work
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

**Key Responsibilities and Accountabilities**:

- Including, but not limited to the following_
- Single point of contact/single point of accountability within GRA on the Core Asset Team (CAT) and Medicines Development Team (MDT) for assigned program(s)
- Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s)
- Provides global regulatory leadership of assigned program(s)
- Develops global regulatory strategies, including risk assessment and mitigation strategies. Champions use of expedited regulatory pathways globally to accelerate patients’ access
- Attends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned program(s)
- May present to Senior Leadership regarding assigned program(s)
- Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners and regulatory consultants
- Participates in strategic and regulatory evaluations of in-licensing matters
- May have direct oversight/management of Regulatory Affairs team members supporting assigned program(s)
- Authority to approve services and costs within budget and delegation from Sobi authorized signatories
- Review regulatory SOPs as needed
- Participate in operational excellence work (improvement projects) as needed.

**Main contacts**:

- Internal core interactions: All functions within Sobi, but in particular Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, Global Medical & Scientific Affairs, Project & Portfolio Management as well as Management Teams, Governance Teams and affiliates.
- External core interactions with: Regulatory Authorities, CROs, Consultants, Partners.
- May act as point of contact with US FDA or EMA

**Qualifications**:

- Degree in Life Sciences
- Good knowledge of drug development and the rare diseases regulatory environment
- Experience in haematology is preferred
- Very good knowledge in written and oral English, knowledge of other languages is an upside but not required

**Additional Information**:
All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

**Why Join Us?**

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

**An Equal Opportunity Employer

  • Director Regulatory Affairs

    vor 2 Monaten

    München, Deutschland Gilead Sciences Vollzeit

    For Current Gilead Employees and Contractors: Please log onto your Internal Career Site At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies...

  • Senior Director, Global Medical Asset Lead Oncology

    vor 3 Monaten

    81677 München, Deutschland Ipsen Pharma GmbH Vollzeit

    **Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?** Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for...

  • Werkstudent Im Bereich Regulatory Affairs

    vor 3 Wochen

    Garching bei München, Deutschland Edwards Lifesciences Vollzeit

    **Starte deine Karriere im **Regulatory Affairs** bei Edwards Lifesciences!** **Du bist Student und suchst nach spannenden Herausforderungen in einem flexiblen Umfeld?** Dann bist du bei uns genau richtig! Wir suchen einen **Werkstudenten (m/w/d) in Regulatory Affairs **an unserem Standort in Garching bei München. **Was erwartet Dich?** - ** Mitwirkung...

  • Head of Regulatory Affairs

    vor 2 Wochen

    München, Deutschland yfood Labs GmbH Vollzeit

    DEINE MISSION - Entwicklung von Zulassungsstrategien für globale Märkte, mit Schwerpunkt auf Europa - Entwicklung und kontinuierliche Verbesserung der internen Prozesse - Berücksichtigung und Umsetzung der nationalen und internationalen Richtlinien im Lebensmittelsektor durch kontinuierliche Überwachung der aktuellen gesetzlichen Regulierungen - Leitung,...

  • Werkstudent in

    vor 1 Monat

    80331 München, Deutschland Kranus Health GmbH Vollzeit

    **DEINE VERANTWORTUNG**: **Werkstudierendentätigkeit gesucht?** Als wachsendes Scaleup sind wir immer auch auf der Suche nach talentierter Unterstützung. Du möchtest während deines Studiums bei uns als Werkstudent:in oder Praktikant:in im Bereich Regulatory Affairs Praxiserfahrung sammeln und hast Lust auf abwechslungsreiche Herausforderungen? Dann...

  • Trainee (W/m/d) Regulatory Affairs Management

    vor 2 Monaten

    81675 München, Deutschland Denk Pharma GmbH & Co. KG Vollzeit

    **Das macht die Denk Pharma**: Seit 1948 ist die DENK PHARMA als Familienunternehmen in mehr als 80 Ländern tätig. Unter unserem Slogan "Quality for your Health - Made in Germany" schaffen wir für alle Kunden mit unseren Produkten Zugang zur Heilung. Als eines der wenigen Pharmaunternehmen weltweit erhalten alle unsere Kunden genau die gleichen Arznei -...

  • Head of Regulatory Affairs

    vor 2 Wochen

    80336 München, Deutschland yfood Labs GmbH Vollzeit

    **DEINE MISSION**: - Entwicklung von Zulassungsstrategien für globale Märkte, mit Schwerpunkt auf Europa - Entwicklung und kontinuierliche Verbesserung der internen Prozesse - Berücksichtigung und Umsetzung der nationalen und internationalen Richtlinien im Lebensmittelsektor durch kontinuierliche Überwachung der aktuellen gesetzlichen Regulierungen -...

  • Vice President, Regulatory and Quality

    vor 3 Wochen

    München, Deutschland Veranex, Inc. Vollzeit

    Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes. **About This Role**: We are seeking an experienced Vice President of Regulatory &...

  • Head of

    vor 2 Monaten

    81675 München, Deutschland Denk Pharma GmbH & Co. KG Vollzeit

    **Das macht die Denk Pharma**: Seit 1948 ist die **DENK PHARMA **als Familienunternehmen in mehr als 80 Ländern tätig. Unter unserem Slogan "Quality for your Health - Made in Germany" schaffen wir für alle Kunden mit unseren Produkten Zugang zur Heilung. Als eines der wenigen Pharmaunternehmen weltweit stellen wir unseren Kunden exakt die gleichen...

  • Qra Dbs Lead

    vor 3 Wochen

    München, Deutschland Beckman Coulter Diagnostics Vollzeit

    **Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.** At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

  • Senior Vice President, Regulatory and Quality

    vor 1 Woche

    München, Deutschland Veranex, Inc. Vollzeit

    Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes. **About This Role**: We are seeking an experienced Vice President or Senior Vice...

  • Director Medical Affairs

    vor 3 Wochen

    München, Deutschland MSD Vollzeit

    An exciting opportunity has arisen for a **Director Medical Affairs General & Specialty Medicine **(all genders). Reporting directly to the Country Medical Director (CMD), you will be responsible for developing and implementing the Global Medical & Scientific Affairs strategy for your Therapeutic Area (TA) in line with global, regional and local...

  • Director Medical Affairs

    vor 2 Monaten

    München, Deutschland Regeneron Pharmaceuticals Inc. Vollzeit

    Our team of expert medical affairs physicians and scientists at Regeneron bridge the gap between our innovative medicines and the scientific and healthcare community. As the Director Medical Affairs Hematology, you will represent Regeneron in Medical Affairs and Clinical Development providing scientific and medical leadership for our Hematology assets. In...

  • Vp Medical Affairs Europe

    vor 2 Wochen

    München, Deutschland Syneos Health Commercial Solutions Vollzeit

    **Description** This role is a European role and can be based from a number of European countries. The Vice President of Medical Affairs Europe will lead the Field Medical Centre of Excellence within the European Region and will have primary accountability to meet or exceed business goals for all assigned field medical teams across the region. They will be...

  • Spezialist Regulatory Affairs

    vor 2 Monaten

    Garching bei München, Deutschland Münchener Hypothekenbank eG Vollzeit

    **Eigenständig - Individuell - Genossenschaftlich** Die Bankenaufsicht in Europa setzt sich aus den nationalen Aufsichtsbehörden und der Europäischen Zentralbank (EZB) zusammen. Für die Aufsicht der Münchener Hypothekenbank als bedeutendes Einzelinstitut ist die EZB direkt zuständig. Sie übernehmen gemeinsam im Team das Reporting an die...

  • Intern Regulatory Affairs Germany

    vor 3 Monaten

    München, Deutschland HypoVereinsbank - UniCredit Vollzeit

    Join our diverse and multi-disciplinary Regulatory Affairs team in Germany for a deep dive into the world of managing the relationship with the banking supervisory authorities. Be part of our global network and profit from an extensive range of areas in practical banking supervision where you can contribute: Coordination of supervisory requests and surveys,...

  • Regulatory Operations Associate

    Vor 3 Tagen

    München, Deutschland Daiichi Sankyo Europe Vollzeit

    Under supervision, provide regulatory operational support for European submission projects for prospective and authorize products in a timely manner. Ensure regulatory operations compliance and may act as a technical specialist in a particular area. In this role, you will be part of a highly competent team resided in Munich and in Basking Ridge/US. **Roles...

  • Vp, Regulatory Compliance

    vor 1 Monat

    80335 München, Deutschland PIMCO Vollzeit

    PIMCO is a global leader in active fixed income with deep expertise across public and private markets. We invest our clients’ capital across a range of fixed income and credit opportunities, leveraging our decades of experience navigating complex debt markets. Our flexible capital base and deep relationships with issuers have helped us become one of the...

  • Compliance Regulatory Liaison, Vice President

    vor 1 Monat

    München, Deutschland State Street Vollzeit

    Who we are looking for: SSBI (State Street Bank International) Compliance Regulatory Liaison reports directly to SSBI Head of Compliance, and collaborates closely with SSBI Senior Management and State Street Global Compliance Regulatory Liaison Office. In this role you will contribute to fostering a positive regulatory culture and promoting proactive...

  • Trainee Regulatory Affairs Germany

    vor 2 Monaten

    München, Deutschland HypoVereinsbank - UniCredit Vollzeit

    Das „**UniCredit Graduate Program**“ ist Dein Start in eine spannende und abwechslungsreiche Karriere in einem der führenden Finanzinstitute Europas. - In Deinem **12- bis 15-monatigen rotationsbasierten Traineeprogramm** lernst Du das Unternehmen ganzheitlich kennen. Du arbeitest in einem zukunftsorientierten und internationalen Umfeld, in dem Du...