Fresenius Kabi
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Full-timeOn-siteManagement
Eysins
New Job?Nejo!
The AI Job Search Engine
FRFresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Eysins
Full-timeOn-siteSenior
Nejo AI Summary
Global regulatory leadership for biosimilar development, managing submission dossiers and health authority meeting preparations. 6-8 years international regulatory experience with global submission (US BLA/EU MAA) required. Global project scope, international team collaboration.
Requirements
- Degree in life science or related disciplines
- At least 6-8 years in international regulatory
- Experience in managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAA
- Experience in working in development project teams
- Experience in leading regulatory agency interactions including management of the associated documentation and rehearsals
- Experience in preparation and coordination of regulatory strategy plan
- Experience in biological development
- Experience in CTA requirements
- Capability to manage a number and range of projects throughout development
- Excellent written and spoken communication skills
- Excellent interpersonal skills
- Understanding of Regulatory Affairs contribution to Pharma business
- Excellent organizational skills, work independently, self-motivated and proactive
- Attention to details, without losing the overall picture
- Ability to think strategically
- Ability to lead regulatory sub team and work in teams
- Autonomous, goal-oriented and pragmatic
- Strong customer-orientation and strong communication skills
- Fluent command of spoken and written English, additional language skills welcome
Tasks
- Provide global regulatory leadership for biosimilar development
- Manage submission-related documents and regulatory data for biosimilars
- Lead preparation and rehearsal for meetings with Health Authorities
- Develop and manage the submission strategy for biosimilar dossiers
- Ensure compliance with Fresenius Kabi regulatory procedures
- Establish regulatory storylines for interactions with authorities
- Collaborate with Regulatory Operations to implement technology strategies
- Support market units in interactions with local health authorities
- Contribute to wave 2 submission prioritization assessments
- Guide Launch Readiness Plans with regulatory process insights
- Lead the Regulatory Sub-team and Strategic Submission Teams as needed
- Act as Regional Lead for US, Canada, or EU regulatory responsibilities
- Manage the regulatory submission process through to approval
- Coordinate regulatory agency interactions and document preparation
- Provide recommendations on submission readiness
- Stay updated on the current regulatory environment
- Interface with other regulatory groups and company functions
- Perform additional tasks to support regulatory objectives
- Drive collaboration with third-party partners for regulatory tasks
- Mentor Junior Regulatory Affairs Leaders
Work Experience
- 6 - 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi SwissBioSim GmbH 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?
- Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSeniorEysins - 206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Manager IV Fluids Global Portfolio(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
Full-timeInternshipOn-siteEysinsfrom CHF 60,000 / year
FRFresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Eysins
Full-timeOn-siteSenior
Nejo AI Summary
Global regulatory leadership for biosimilar development, managing submission dossiers and health authority meeting preparations. 6-8 years international regulatory experience with global submission (US BLA/EU MAA) required. Global project scope, international team collaboration.
Requirements
- Degree in life science or related disciplines
- At least 6-8 years in international regulatory
- Experience in managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAA
- Experience in working in development project teams
- Experience in leading regulatory agency interactions including management of the associated documentation and rehearsals
- Experience in preparation and coordination of regulatory strategy plan
- Experience in biological development
- Experience in CTA requirements
- Capability to manage a number and range of projects throughout development
- Excellent written and spoken communication skills
- Excellent interpersonal skills
- Understanding of Regulatory Affairs contribution to Pharma business
- Excellent organizational skills, work independently, self-motivated and proactive
- Attention to details, without losing the overall picture
- Ability to think strategically
- Ability to lead regulatory sub team and work in teams
- Autonomous, goal-oriented and pragmatic
- Strong customer-orientation and strong communication skills
- Fluent command of spoken and written English, additional language skills welcome
Tasks
- Provide global regulatory leadership for biosimilar development
- Manage submission-related documents and regulatory data for biosimilars
- Lead preparation and rehearsal for meetings with Health Authorities
- Develop and manage the submission strategy for biosimilar dossiers
- Ensure compliance with Fresenius Kabi regulatory procedures
- Establish regulatory storylines for interactions with authorities
- Collaborate with Regulatory Operations to implement technology strategies
- Support market units in interactions with local health authorities
- Contribute to wave 2 submission prioritization assessments
- Guide Launch Readiness Plans with regulatory process insights
- Lead the Regulatory Sub-team and Strategic Submission Teams as needed
- Act as Regional Lead for US, Canada, or EU regulatory responsibilities
- Manage the regulatory submission process through to approval
- Coordinate regulatory agency interactions and document preparation
- Provide recommendations on submission readiness
- Stay updated on the current regulatory environment
- Interface with other regulatory groups and company functions
- Perform additional tasks to support regulatory objectives
- Drive collaboration with third-party partners for regulatory tasks
- Mentor Junior Regulatory Affairs Leaders
Work Experience
- 6 - 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi SwissBioSim GmbH 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?
- Fresenius Kabi
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Full-timeOn-siteManagementEysins - Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSeniorEysins - 206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Manager IV Fluids Global Portfolio(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
Full-timeInternshipOn-siteEysinsfrom CHF 60,000 / year