New Job?Nejo!

The AI Job Search Engine

AL
Alnylam Pharmaceuticals, Inc.
19d ago

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

München
Full-timeWith Home OfficeSenior

Description

You will lead the company's regulatory strategy in Germany, bridging the gap between global goals and local execution while navigating complex health authority interactions and product launches.

Let AI find the perfect jobs for you!

Upload your CV and Nejo AI will find matching job offers for you.

Requirements

  • •University degree in Life Sciences, related field, or advanced degree
  • •10+ years Regulatory Affairs experience in pharma or biotech
  • •Success in regulatory negotiations and German health authority relationships
  • •Deep understanding of German regulatory environment and compliance standards
  • •Ability to lead cross-functional teams and influence stakeholders
  • •Excellent communication and fluency in German and English
  • •High initiative, resilience, and adaptability
  • •Willingness to travel as needed

Education

Bachelor's degree
OR
Master's degree

Tasks

  • •Translate global regulatory strategies into German market execution
  • •Advise the General Manager and senior leadership on strategy
  • •Anticipate regulatory trends to position the company for success
  • •Develop actionable business plans and risk mitigation strategies
  • •Lead negotiations and meetings with German health authorities
  • •Manage regulatory planning for local product launches
  • •Oversee national submissions including PZN codes and RMP materials
  • •Approve promotional and medical materials for local compliance
  • •Provide regulatory input for supply chain and quality operations
  • •Implement regulatory systems to ensure operational excellence
  • •Represent regulatory interests in local cross-functional forums
  • •Partner with external consultants and industry stakeholders
  • •Participate in local industry associations to shape legislation

Languages

German – Business Fluent

English – Business Fluent

Benefits

Flexible Working

  • •Hybrid work model

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.
Not a perfect match?
100+ Similar Jobs in München
  • Eßmann Personalberatung

    Associate Director Regulatory Affairs(m/w/x)

    Full-timeWith HomeofficeSenior
    from 135,000 / year
    München
  • ITM Isotope Technologies Munich SE

    Director, Early Development Regulatory Lead(m/w/x)

    Full-timeWith HomeofficeSenior
    Garching bei München
  • Idorsia

    Associate Director Legal & Compliance -DACH(m/w/x)

    Full-timeWith HomeofficeSenior
    München
  • BeOne Medicines Germany GmbH

    Senior Manager / Associate Director Corporate Affairs(m/w/x)

    Full-timeWith HomeofficeSenior
    München
  • DENK Family

    Manager International Regulatory Affairs(m/w/x)

    Full-timeWith HomeofficeManagement
    München
100+ View all similar jobs
Apply now