Novocure Inc
Principal Regulatory Affairs Specialist(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Baar
TA
Takeda Development Center Americas, Inc.2 Monate
Associate Director, Global Regulatory Affairs, Advertising and Promotion(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Zürich
Nejo KI-Zusammenfassung
In this role, you will be the go-to expert for regulatory affairs in advertising and promotion, guiding the development and review of materials while ensuring compliance and patient safety. Your strategic insights will shape the product lifecycle from clinical trials to marketing, all while fostering teamwork and effective communication.
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Anforderungen
- •BSc Degree or BA
- •8+ years of pharmaceutical industry experience
- •6 years of regulatory experience or 5+ years regulatory and/or related experience
- •Understanding of ABPI, EFPIA and international advertising codes
- •Experience in prescription medicine promotion development
- •Strong interpersonal skills
- •Ability to communicate clearly and concisely
- •Effective written and verbal communication skills
- •Proven negotiation and influencing skills
- •Cross-functional people management skills
- •Ability to work independently and meet deadlines
- •Previous experience in advertising and promotion role
- •Experience in regulatory affairs, particularly advertising and promotion
- •Strong leadership and conflict resolution skills
- •Strategic mindset for regulatory impacts assessment
- •Guiding teams through advertising and promotion processes
Bachelor-Abschluss
Berufserfahrung
8 Jahre
Deine Aufgaben
- •Act as the Subject Matter Expert for assigned products and projects
- •Provide regulatory guidance during the development and review of medical and commercial materials
- •Serve as the Regulatory Advisor in the Medical, Legal, and Regulatory review process
- •Lead global CMRP as the product or project business lead
- •Chair CMRP meetings and facilitate communication among team members
- •Negotiate and resolve team disputes while maintaining focus on patient needs
- •Oversee escalation steps for alignment on new data or campaigns
- •Partner strategically from clinical trial development through product marketing
- •Provide expertise on EFPIA, IFPMA, and FDA codes and regulations
- •Ensure compliance and patient safety within the CMRP
- •Lead and motivate team members to achieve organizational goals
- •Identify and implement processes for reviewing promotional materials
- •Advocate for and implement positive change within the organization
- •Analyze complex issues and propose effective solutions
- •Communicate clearly and concisely in all interactions
- •Adapt to various personalities to foster goal achievement
- •Collaborate effectively in a cross-functional team environment
- •Create and deliver impactful presentations with focused recommendations
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Takeda Development Center Americas, Inc. 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.
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