Ultragenyx Pharmaceutical
Senior Medical Director EMEA, Neurosciences(m/w/x)
Vollzeitnur vor OrtSenior
Zürich
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
TATakeda Pharmaceuticals International AG
Associate Director, EU Regulatory Lead Neuroscience(m/w/x)
Zürich
ab CHF 159.300 - 219.010 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading EU regulatory strategies for neuroscience products, supporting registration and lifecycle management. Minimum 8 years EU drug regulatory affairs experience required. Work with global teams, navigate European regulatory environment.
Anforderungen
- Bachelor’s degree in scientific discipline
- Advanced scientific degree
- Minimum 8 years drug regulatory affairs experience
- Significant EU region experience
- Strong knowledge EU regulatory requirements
- Knowledge of basic regulatory requirements in other regions
- Develop and execute regional regulatory strategies
- Experience with investigational regulatory submissions
- Participate in or lead Health Authority interactions
- Strong strategic thinking
- Assess regulatory opportunities, risks, and mitigation strategies
- Excellent communication skills
- Excellent influencing skills
- Excellent stakeholder management skills
- Assertive authority whom peers trust
- Fluent in English
- Ability to work independently in complex environment
- Willingness to travel internationally
Aufgaben
- Define and lead regional regulatory strategies
- Support product development and registration
- Manage patient access and lifecycle management
- Work with global and regional teams
- Navigate European regulatory environment
- Drive high-quality regulatory submissions
- Lead interactions with Health Authorities
- Develop and execute EU regulatory strategies
- Manage regional regulatory submissions
- Ensure timely approvals
- Provide regulatory guidance to project teams
- Lead Submission Working Groups
- Represent EU region on global teams
- Prepare for regulatory meetings
- Communicate meeting outcomes effectively
- Assess regulatory trends and requirements
- Translate trends into proactive strategies
- Provide expertise in drug development
- Support registration and post-marketing activities
- Manage lifecycle management activities
- Support value and access interactions
- Build relationships with Regulatory Affairs teams
- Collaborate with cross-functional partners
- Engage with external experts and authorities
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Takeda Pharmaceuticals International AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- Denali Therapeutics IncAssociate Director, Safety Ops(m/w/x)Vollzeitnur vor OrtSeniorZürich
- Novo NordiskAssociate Director, Executive Assistant & Strategic Partner(m/w/x)Vollzeitnur vor OrtSeniorZürich
- Takeda Pharmaceuticals International AGHead of Ethics and Compliance Europe(m/w/x)Vollzeitnur vor OrtSeniorZürichab CHF 263.300 - 362.010 / Jahr
- Teleflex IncorporatedAsc Regulatory Affairs Specialist(m/w/x)Vollzeitnur vor OrtBerufserfahrenBülach