AL
Alnylam Pharmaceuticals, Inc.
14 Tage

Associate Director, Local Regulatory Lead - Switzerland and Austria(m/w/x)

Vollzeit
mit Homeoffice
Senior
Keine Angabe
Zug

In this strategic leadership role, you will translate global regulatory strategies into local execution while collaborating with cross-functional teams. Your day-to-day responsibilities will involve engaging with health authorities, managing submissions, and shaping regulatory direction in Switzerland and Austria.

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Anforderungen

  • •University degree in life sciences, pharmacy, medicine, or related field
  • •At least 8 years in Regulatory Affairs within the pharmaceutical or biotech industry
  • •Proven success in leading regulatory negotiations
  • •Deep understanding of Swiss and EU regulatory environment
  • •Demonstrated ability to work with cross-functional teams
  • •Excellent communication skills with fluency in German and English
  • •High degree of initiative, resilience, and adaptability
  • •Willingness to travel as needed
Master-Abschluss
ODER
Doktor / Ph.D.

Berufserfahrung

8 Jahre

Deine Aufgaben

  • •Translate global regulatory strategy to local execution
  • •Act as a strategic advisor to the Country General Manager
  • •Anticipate regulatory trends in Swiss and Austrian markets
  • •Develop actionable business plans from complex regulatory landscapes
  • •Serve as the primary liaison with Swissmedic and AGES health authorities
  • •Lead regulatory interactions, negotiations, and meetings
  • •Manage local MA submissions and lifecycle management in Switzerland
  • •Oversee product launches and compliance initiatives
  • •Review and approve promotional, medical, and educational materials
  • •Provide regulatory input for supply chain and quality operations
  • •Drive implementation of regulatory systems and processes
  • •Represent Global Regulatory Sciences in local cross-functional forums
  • •Lead cross-functional regulatory initiatives within the affiliate
  • •Build partnerships with external consultants and industry stakeholders
  • •Monitor and participate in local legislation and regulatory guidance

Sprachen

Deutsch – verhandlungssicher

Englisch – verhandlungssicher

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