Project Manager, CMC Regulatory Affairs, Luzern

Vor 2 Tagen

Luzern, Schweiz TN Switzerland Vollzeit

Social network you want to login/join with:

Project Manager, CMC Regulatory Affairs, LuzernClient:

1925 GlaxoSmithKline LLC

Location:Job Category:

Other

Job Reference:

34e4ca8b5d9a

Job Views:

10

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.

The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

Key Responsibilities:

  • Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
  • Responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with the applicable regulatory & scientific standards.
  • Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the submission, review and approval of global CMC applications.
  • Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensures information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
  • Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
  • Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
  • Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
  • Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
  • Will sometimes deliver CMC regulatory strategy to support major inspections (e.g. PAIs) with managerial support.

Basic Qualifications:

  • BS in a Life Sciences or related field.
  • Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
  • Two or more years of experience in drug development, manufacturing processes and supply chain and may have a specialized area of expertise.

Preferred Qualifications:

  • MS in a Life Sciences or related field.
  • RAPS Certification.
  • Pre-approval experience (phase 1 to phase 3 submission experience).
  • Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.

Please visit to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

#J-18808-Ljbffr

  • Project Manager, CMC Regulatory Affairs

    Vor 2 Tagen

    Luzern, Schweiz 1925 GlaxoSmithKline LLC Vollzeit

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

  • Regulatory Affairs Manager

    Vor 2 Tagen

    Luzern, Schweiz LHH Vollzeit

    Unser Mandat ist ein innovatives und global vernetztes Medizintechnikunternehmen, welches für sein Entwicklungs-Know-How im Bereich der medizinischen Diagnostik bekannt ist. Mit mehr als 15 Jahren Erfahrung und 100 Mitarbeitern in 4 Niederlassungen verzeichnet unser Mandant in den letzten Jahren ein starkes Wachstum und sucht zum nächstmöglichen Zeitpunkt...

  • Clinical Project Manager

    Vor 2 Tagen

    Luzern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Job Title: Clinical Project Manager – VaccinesCompany Overview: Join a leading biotechnology company at the forefront of vaccine development, dedicated to improving global health through innovative solutions.Position Overview: The Clinical Project Manager (CPM) will oversee the planning, execution, and completion...

  • Junior Project Manager 100%

    vor 2 Wochen

    Luzern, Schweiz Veolia Vollzeit

    **Company Description**: **The Sonderabfallverwertungs-AG SOVAG,** a subsidiary of SARP Industries (a company of the VEOLIA Group) the leading player in Europe for the treatment and recovery of hazardous waste, is looking **for our Project in Emmenbrücke a motivated** **Junior Project Manager 100%** **What is our project about?**- Obtaining a permit for a...

  • Clinical Affairs Coordinator

    Vor 3 Tagen

    Luzern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Clinical Affairs Coordinator (m/f/d), LucerneClient:HaysLocation:LucerneJob Category:OtherJob Reference:0a7b9b57121fJob Views:12Posted:21.01.2025Expiry Date:07.03.2025Job Description:Clinical Affairs Coordinator (m/f/d)Freelance/temporary employment for a project in Lucerne. Start date: asap. Reference number:...

  • Junior Project Manager 100%

    vor 2 Wochen

    Luzern, Schweiz Veolia Vollzeit

    **Company Description**: **The Sonderabfallverwertungs-AG SOVAG,** a subsidiary of SARP Industries (a company of the VEOLIA Group) the leading player in Europe for the treatment and recovery of hazardous waste, is looking **for our Project in Emmenbrücke a motivated** **Junior Project Manager 100%** **What is our project about?**- Obtaining a permit for a...

  • Sales Manager

    Vor 2 Tagen

    Luzern, Schweiz Europa-Park GmbH & Co Mack KG Vollzeit

    **Wir bieten Dir** - Einen sicheren und modernen Arbeitsplatz mit spannenden und ungewöhnlichen Herausforderungen - Eine Start-up-Mentalität mit kurzen Entscheidungswegen eine modern und exzellent ausgestattete Arbeitsumgebung - Einen Arbeitsplatz mit der Möglichkeit zur beruflichen und persönlichen Weiterentwicklung innerhalb des Unternehmens - Eine...

  • Technical Project Manager

    vor 2 Wochen

    Luzern, Schweiz Consulteer Vollzeit

    **Technical Project Manager**: Lead challenging technical projects. LUCERNE **Your Role and Responsibility** - Creation of the project management plan. - Ensure that the project management plan is valid and up to date. - Formulate assignments to project team members to produce each deliverable, monitor and, if necessary, initiate corrective measures. -...

  • ICT Produkt-/ Service Manager/in

    Vor 3 Tagen

    Luzern, Schweiz Kanton Luzern Vollzeit

    Arbeiten beim Kanton Luzern heisst, die Zukunft mitzugestalten - die des Kantons, seiner Einwohnerinnen und Einwohner und nicht zuletzt die eigene. Zur ausgezeichneten Lebensqualität in unserem Kanton leisten täglich mehr als 6'000 Mitarbeiterinnen und Mitarbeiter in 200 verschiedenen Berufen ihren Beitrag.Die Dienststelle Informatik (DIIN) erbringt...

  • Cra Manager

    Vor 7 Tagen

    Luzern, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Junior Project Manager

    Vor 7 Tagen

    Luzern, Schweiz WEBKINDER AG Vollzeit

    **Junior Project Manager, 80-100% Pensum** Lust auf Web? Bist du zuverlässig und können wir auf dich zählen? Dann erwartet dich das Agenturleben und viele spannende Projekte bei uns. Bringst du gute Social Skills mit, nimmt dich ein herzliches und fleissiges Team aus vierzehn jungen Menschen auf. Zusammen gestalten und realisieren wir komplexe, moderne...

  • Commercial Business Development Manager Vaccines

    vor 1 Tag

    Luzern, Schweiz MSD Vollzeit

    We are currently looking for a field based **Commercial Business Development Manager Vaccines (M/F/d)** with national responsibility who will maximize the growth of our private market vaccines sales across Switzerland. They will report to the Business Unit Director, Vaccines, and work closely with colleagues from a range of functions including Marketing,...

  • Corner Manager

    Vor 5 Tagen

    Luzern, Schweiz Sephora Switzerland Vollzeit

    Corner Manager - Luzern 100% **Profile**: Bei** Sephora** steckt Beauty in unserer DNA - „Leidenschaft“ geht Hand in Hand mit „Kreativität“: Immer auf der Suche nach Neuheiten und Trends, strotzen wir vor Energie, um unsere Kunden mit unserer Auswahl an grossartigen Beauty Produkten zu begeistern. Bei uns geht das „Lernen“ einher mit...

  • Facility Quality Compliance Manager

    vor 1 Tag

    Luzern, Schweiz TN Switzerland Vollzeit

    Facility Quality Compliance Manager, LucerneClient:CK GroupLocation:LucerneJob Category:OtherJob Reference:1f65679b93b3Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:Facility Quality Compliance ManagerCK QLS are looking for a Facility Quality Compliance Manager to join a Global Biopharmaceutical company, based in Lucerne, for 12 months....

  • Ice Cream Boutique Manager Luzern

    Vor 6 Tagen

    Luzern, Schweiz Cuckoo Ice Cream Vollzeit

    cuckoo gastronomie ag, ein junges Eisunternehmen. Wir suchen derzeit einen motivierten und erfahrenen Ice Cream Boutique Manager, der unser Team in Luzern verstärkt und unsere Kunden mit ihrem Geschmackserlebnis glücklich macht. Verantwortlichkeiten: Verwalten Sie den täglichen Betrieb der Ice Cream Boutiqu Sorgen Sie für einen qualitativ hochwertigen...

  • Digital Marketing Manager

    Vor 7 Tagen

    Luzern, Schweiz Mandarin Oriental Palace Luzern Vollzeit

    Assistenz / Sekretariat Sind Sie bereit für eine neue Herausforderung? Wir suchen ab sofort eine:n Digital Marketing Manager für unser Mandarin Oriental Palace, Luzern Team! Das legendäre Hotel Palace Luzern wurde erstmals im Jahr 1906 eröffnet und befindet sich im Herzen der Stadt Luzern, am Ufer des Vierwaldstättersees. Das Hotel verfügt über...

  • Supply Chain Specialist

    Vor 2 Tagen

    Luzern, Schweiz TN Switzerland Vollzeit

    Supply Chain Specialist - II - P2Client:CK GroupLocation:LucerneJob Category:OtherJob Reference:4e5629e02fa9Job Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:Job Title: New Product Introduction Specialist (Supply Chain Specialist II)Work Location: LucerneDuration: 12 monthsYour main duties as a New Product Introduction Specialist will...

  • Store Manager

    Vor 5 Tagen

    Luzern, Schweiz ONLY Stores Switzerland AG Vollzeit

    Wir, ONLY Stores Switzerland AG, als eine Bestseller Retail-Partner Gesellschaft, suchen zur erfolgreichen Expansion unseres Unternehmens und zur weiteren Optimierung unseres Markenauftritts ONLY an unserem Standort LUZERN, zur Verstärkung unseres Teams engagierte und kompetente Unterstützung als **Store Manager (m/w/d)** Standort: Luzern Als Shop...

  • Assistant Restaurant Manager

    Vor 6 Tagen

    Luzern, Schweiz Mandarin Oriental Palace Luzern Vollzeit

    Sind Sie bereit für eine neue Herausforderung? Wir suchen ab sofort eine:n Assistant Restaurant Manager für unser Mandarin Oriental Palace, Luzern Team! Das legendäre Hotel Palace Luzern wurde erstmals im Jahr 1906 eröffnet und befindet sich in Luzern am Ufer des Vierwaldstättersees. Nach einer kompletten Renovierung eröffnete das Mandarin...

  • Supply Chain Expert

    Vor 2 Tagen

    Luzern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Supply Chain Expert - Labelling and Translation (m/f/d)Client: HaysLocation: LucerneJob Category: OtherJob Reference: 7d5c2f074189Job Views: 10Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Supply Chain Expert - Labelling and Translation (m/f/d)Freelance/temporary employment for a project in Luzern. Start...