Viatris Pharma GmbH
Regulatory Affairs Manager(m/w/x)
Full-timeOn-siteExperienced
Zug
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GIGilead Sciences Switzerland Sarl
Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate(m/w/x)
Zug
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring Swiss affiliate regulatory compliance for HIV, hepatitis, COVID-19, and cancer therapies. Significant biopharma regulatory, quality, and compliance experience required. Cross-functional partnership and independent decision-making for complex projects.
Requirements
- Significant regulatory, quality, compliance experience in biopharma
- Proven track record in setting and directing regulatory strategy
- Experience negotiating with regulatory authorities
- Manage complex negotiations with regulatory authorities
- Independent decision-making for complex projects
- Participating in cross-functional projects for clinical trials
- Effective delegation and management of others
- Line management (direct reports) experience strongly preferred
- Experience with Gilead therapeutic areas strongly preferred
- 10+ years RA experience with BS/BA or 8+ years RA experience with advanced degree
- Understanding and implementing regulatory requirements (ICH, regional)
- Developing and implementing regulatory initiatives
- Knowledge in quality assurance, promotional/non-promotional review, Pharmacovigilance, market access advantageous
- Excellent working knowledge of national/regional Regulatory Authorities
- German preferred mother tongue, English fluent, French/Italian advantageous
Tasks
- Serve as a core member of the Swiss Affiliate Regulatory Team
- Partner cross-functionally with business units
- Represent Regulatory function and Dev Ops in internal and external meetings
- Ensure compliance with country-specific regulations and legislation
- Develop and maintain medicinal products on the market
- Lead or participate in cross-functional project teams locally, regionally, and globally
- Contribute to the vision and direction of the RA organization
- Set clear goals and objectives aligned with global Dev Ops strategy
- Fulfill requirements linked to the MA/local license as MA Holder
- Support crisis management and leadership team
- Contribute to resource and budget planning
- Communicate important changes to the local Regulatory and Dev Ops function
- Prepare and lead challenging regulatory submissions
- Coordinate cross-functional responses and act as main point of contact for local HA
- Support country/national scientific advice and pre-submission meetings
- Manage strict timelines for submission and variation approval
- Ensure compliant labeling for Gilead medicinal products
- Provide regulatory expertise for labeling changes and submission teams
- Contribute to international and global regulatory strategy
- Ensure compliance with local law and global procedural documents
- Act as subject matter expert or audit/inspection lead
- Initiate and contribute to local and global process improvements
- Review and submit promotional material to HA
- Serve as a core member of country brand/launch teams
- Consult on Affiliate matters for local, regional, and global RA teams
- Conduct risk assessments on local regulatory issues
- Develop mitigation strategies for regulatory changes
- Stay updated on major changes in regulatory legislation and competitor information
- Contribute to guideline and regulation development
- Optimize outcomes for regulatory changes
- Build recognition as a thought leader in RA and Dev Ops
- Lead work in additional countries as required
- Mentor, train, and coach regulatory and non-regulatory staff
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- German – Native
- English – Business Fluent
- French – Basic
- Italian – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Gilead Sciences Switzerland Sarl 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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GIGilead Sciences Switzerland Sarl
Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate(m/w/x)
Zug
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring Swiss affiliate regulatory compliance for HIV, hepatitis, COVID-19, and cancer therapies. Significant biopharma regulatory, quality, and compliance experience required. Cross-functional partnership and independent decision-making for complex projects.
Requirements
- Significant regulatory, quality, compliance experience in biopharma
- Proven track record in setting and directing regulatory strategy
- Experience negotiating with regulatory authorities
- Manage complex negotiations with regulatory authorities
- Independent decision-making for complex projects
- Participating in cross-functional projects for clinical trials
- Effective delegation and management of others
- Line management (direct reports) experience strongly preferred
- Experience with Gilead therapeutic areas strongly preferred
- 10+ years RA experience with BS/BA or 8+ years RA experience with advanced degree
- Understanding and implementing regulatory requirements (ICH, regional)
- Developing and implementing regulatory initiatives
- Knowledge in quality assurance, promotional/non-promotional review, Pharmacovigilance, market access advantageous
- Excellent working knowledge of national/regional Regulatory Authorities
- German preferred mother tongue, English fluent, French/Italian advantageous
Tasks
- Serve as a core member of the Swiss Affiliate Regulatory Team
- Partner cross-functionally with business units
- Represent Regulatory function and Dev Ops in internal and external meetings
- Ensure compliance with country-specific regulations and legislation
- Develop and maintain medicinal products on the market
- Lead or participate in cross-functional project teams locally, regionally, and globally
- Contribute to the vision and direction of the RA organization
- Set clear goals and objectives aligned with global Dev Ops strategy
- Fulfill requirements linked to the MA/local license as MA Holder
- Support crisis management and leadership team
- Contribute to resource and budget planning
- Communicate important changes to the local Regulatory and Dev Ops function
- Prepare and lead challenging regulatory submissions
- Coordinate cross-functional responses and act as main point of contact for local HA
- Support country/national scientific advice and pre-submission meetings
- Manage strict timelines for submission and variation approval
- Ensure compliant labeling for Gilead medicinal products
- Provide regulatory expertise for labeling changes and submission teams
- Contribute to international and global regulatory strategy
- Ensure compliance with local law and global procedural documents
- Act as subject matter expert or audit/inspection lead
- Initiate and contribute to local and global process improvements
- Review and submit promotional material to HA
- Serve as a core member of country brand/launch teams
- Consult on Affiliate matters for local, regional, and global RA teams
- Conduct risk assessments on local regulatory issues
- Develop mitigation strategies for regulatory changes
- Stay updated on major changes in regulatory legislation and competitor information
- Contribute to guideline and regulation development
- Optimize outcomes for regulatory changes
- Build recognition as a thought leader in RA and Dev Ops
- Lead work in additional countries as required
- Mentor, train, and coach regulatory and non-regulatory staff
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- German – Native
- English – Business Fluent
- French – Basic
- Italian – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Gilead Sciences Switzerland Sarl 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Gilead Sciences Switzerland Sarl
Industry
Pharmaceuticals
Description
The company develops therapies for diseases such as HIV, viral hepatitis, COVID-19, and cancer, aiming to improve lives globally.
Not a perfect match?
- Viatris Pharma GmbH
Regulatory Affairs Manager(m/w/x)
Full-timeOn-siteExperiencedZug - Viatris Pharma GmbH
Head of Quality Assurance(m/w/x)
Full-timeOn-siteSeniorZug, Steinhausen - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Cytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSeniorZug - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz