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ALAlnylam Pharmaceuticals, Inc.

Associate Director, Regulatory Affairs(m/w/x)

Zug
Full-timeOn-siteSenior

Translating global regulatory strategies for RNAi-based medicines, advising senior leadership on Swiss/Austrian market trends. Success leading regulatory negotiations with Swiss/Austrian authorities and deep Swiss/EU regulatory understanding essential. Pioneering work in RNAi-based medicine development.

Requirements

  • Degree in life sciences, pharmacy, medicine, or related field
  • 8 years Regulatory Affairs experience in pharma or biotech
  • Success leading regulatory negotiations with Swiss/Austrian authorities
  • Deep understanding of Swiss and EU regulatory environment
  • Ability to influence stakeholders and drive strategic alignment
  • Excellent communication and fluency in German and English
  • High initiative, resilience, and adaptability
  • Willingness to travel as needed

Tasks

  • Translate global regulatory strategies into local execution plans
  • Advise the General Manager and senior leadership on strategy
  • Anticipate regulatory trends in Swiss and Austrian markets
  • Convert complex regulatory landscapes into actionable business plans
  • Liaise with Swissmedic and AGES health authorities
  • Lead local marketing authorization and lifecycle management submissions
  • Oversee product launches and regulatory compliance initiatives
  • Approve promotional, medical, and educational materials
  • Provide regulatory input for supply chain and quality operations
  • Implement regulatory systems to ensure operational excellence
  • Represent Global Regulatory Sciences in cross-functional forums
  • Coordinate initiatives across Commercial, Medical, and Quality teams
  • Manage partnerships with external consultants and industry stakeholders
  • Monitor and influence local legislation and regulatory guidance

Education

  • Master's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Benefits

Informal Culture

  • Inclusive recruitment process

Other Benefits

  • Equal employment opportunity
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alnylam Pharmaceuticals, Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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