Viatris Pharma GmbH
Regulatory Affairs Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Zug
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GIGilead Sciences Switzerland Sarl
Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate(m/w/x)
Zug
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – fließend
- Englisch – verhandlungssicher
- Französisch – Grundkenntnisse
- Italienisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Gilead Sciences Switzerland Sarl erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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GIGilead Sciences Switzerland Sarl
Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate(m/w/x)
Zug
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – fließend
- Englisch – verhandlungssicher
- Französisch – Grundkenntnisse
- Italienisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Gilead Sciences Switzerland Sarl erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Gilead Sciences Switzerland Sarl
Branche
Pharmaceuticals
Beschreibung
The company develops therapies for diseases such as HIV, viral hepatitis, COVID-19, and cancer, aiming to improve lives globally.
Noch nicht perfekt?
- Viatris Pharma GmbH
Regulatory Affairs Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZug - Viatris Pharma GmbH
Head of Quality Assurance(m/w/x)
Vollzeitnur vor OrtSeniorZug, Steinhausen - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Cytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Vollzeitnur vor OrtSeniorZug - AbbVie
Senior Government Affairs Manager(m/w/x)
Vollzeitnur vor OrtSeniorCham