Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Full-timeWith HomeofficeSenior
München
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ALAlnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading negotiations with German health authorities for RNAi-based medicines at biotech developing genetic disease treatments. 10+ years Regulatory Affairs experience in pharma/biotech with German health authority negotiation success required. Hybrid work model.
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
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
Education
- Bachelor's degreeOR
- Master's degree
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.
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ALAlnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading negotiations with German health authorities for RNAi-based medicines at biotech developing genetic disease treatments. 10+ years Regulatory Affairs experience in pharma/biotech with German health authority negotiation success required. Hybrid work model.
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
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
Education
- Bachelor's degreeOR
- Master's degree
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.
About the Company
Alnylam Pharmaceuticals, Inc.
Industry
Pharmaceuticals
Description
The company has led the RNAi Revolution and develops innovative medicines to treat diseases at their genetic source.
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