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Alnylam Pharmaceuticals, Inc.
27d ago

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

Zug
Full-timeWith Home OfficeSenior

Description

As a strategic leader for Switzerland and Austria, you will drive regulatory excellence by translating global strategies into local success while managing vital relationships with health authorities.

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Requirements

  • •University degree in life sciences, pharmacy, medicine, or related field
  • •Eight years Regulatory Affairs experience in pharma or biotech
  • •Success in leading regulatory negotiations with health authorities
  • •Deep understanding of Swiss and EU regulatory environment
  • •Ability to work with cross-functional teams and stakeholders
  • •Excellent communication skills and fluency in German and English
  • •High degree of initiative, resilience, and adaptability
  • •Willingness to travel as needed

Education

Master's degree
OR
Doctoral / PhD

Tasks

  • •Translate global regulatory strategies into local execution plans
  • •Advise the Country General Manager and senior leadership
  • •Anticipate market trends to position the company for success
  • •Convert complex regulatory landscapes into actionable business plans
  • •Liaise with Swissmedic and AGES health authorities
  • •Lead negotiations and meetings with national health agencies
  • •Manage marketing authorization submissions and product launches
  • •Oversee lifecycle management 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 regulatory initiatives across commercial and medical departments
  • •Partner with external consultants and industry stakeholders
  • •Monitor and influence upcoming local legislation and guidance

Languages

German – Business Fluent

English – Business Fluent

Benefits

Flexible Working

  • •Hybrid onsite and remote working
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