Project Manager, CMC Regulatory Affairs
vor 2 Wochen
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 (eg PAIs) with managerial supportBasic 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 expertisePreferred Qualifications:
MS in a Life Sciences or related field. RAPS Certification Biologics experience Veeva Vault experience 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.
-
Regulatory Affairs Manager
vor 2 Wochen
Luzern, Schweiz LHH VollzeitUnser 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...
-
Regulatory Affairs Manager
vor 2 Monaten
Luzern, Schweiz LHH VollzeitUnser Mandat ist ein weltweit vernetztes Medizintechnikunternehmen, das für seine Spitzenkompetenz in der medizinischen Diagnostik bekannt ist. Für die Niederlassung im Grossraum Luzern suchen wir Verstärkung durch einen **Regulatory Affairs Manager (w/m/d)**. **Aufgabengebiet** - Zulassungsdokumentation für EU- und Nicht-EU-Länder erstellen und...
-
Senior Specialist, Regulatory Affairs
Vor 5 Tagen
Luzern, Luzern, Schweiz Organon VollzeitJob DescriptionSenior Specialist Regulatory Affairs - DACH**Please apply with CV in English**DEINE AUFAGBEN:Zulassung und Lifecycle Management für Arzneimittel und Medizinprodukte im DACH (Deutschland, Österreich und der Schweiz)Vorbereitung, Prüfung und Erstellung von Zulassungsdokumenten und Einreichung bei relevanten Behörden Erarbeiten von Strategien...
-
Senior Specialist, Regulatory Affairs
Vor 6 Tagen
Luzern, Schweiz Organon VollzeitJob DescriptionSenior Specialist Regulatory Affairs - DACH**Please apply with CV in English**DEINE AUFAGBEN:Zulassung und Lifecycle Management für Arzneimittel und Medizinprodukte im DACH (Deutschland, Österreich und der Schweiz)Vorbereitung, Prüfung und Erstellung von Zulassungsdokumenten und Einreichung bei relevanten Behörden Erarbeiten von Strategien...
-
Luzern, Luzern, Schweiz Biomed AG VollzeitIhr Aufgabengebiet:Betreuung und Pflege der Zulassungsdossiers der vertriebenen Arzneimittel.Begleitung der Produktion von im Lohnauftrag hergestellten Arzneimitteln bezüglich Zulassung und Qualität, Koordination mit Partnern und Lohnherstellern.Unterstützung bei der Beurteilung und Freigabe von Werbung für Arzneimittel und Medizinprodukte.Aktive...
-
Technical Project Manager
vor 3 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. -...
-
Project Manager
vor 2 Wochen
Luzern, Schweiz Manpower VollzeitAt Manpower Switzerland, we are dedicated to helping individuals find permanent or temporary jobs, providing new challenges, supporting professional development, and offering job search advice. Each year, over 20,000 people trust us to connect them with opportunities. We partner with more than 5,000 companies, from small businesses to multinational...
-
Cra Manager
vor 2 Wochen
Luzern, Schweiz MSD VollzeitWe 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...
-
Commercial Business Development Manager Vaccines
vor 1 Woche
Luzern, Schweiz MSD VollzeitWe 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,...
-
Cra Manager
Vor 5 Tagen
Luzern, Luzern, Schweiz MSD VollzeitWe 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...
-
Clinical Research Manager
vor 4 Wochen
Luzern, Schweiz MSD VollzeitWe 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...
-
Team Leader Project Manager
Vor 5 Tagen
Luzern, Luzern, Schweiz Pilatus Aircraft Ltd VollzeitTeam Leader Project Manager Fly with us into the future and become part of the team at one of the most innovative aircraft manufacturers in the world. ENGINEERING & TRAINING SYSTEMS PROJECT MANAGEMENT PC-12 AIRCRAFT Your place of work: Stans, Switzerland Your Tasks Lead a team of 5 internal and external staffFormulate project plans for assigned development...
-
Project Manager
Vor 6 Tagen
Luzern, Schweiz WEBKINDER AG Vollzeit**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 sechzehn jungen Menschen auf. Zusammen gestalten und realisieren wir komplexe, moderne und...
-
Mitarbeiter:in Public Affairs 60
vor 1 Monat
Luzern, Luzern, Schweiz Suva VollzeitLuzern unbefristet Eine Aufgabe bei der Suva ist weit mehr, als einfach nur seiner Arbeit nachzugehen. Bei uns kannst du dich einbringen und Verantwortung übernehmen. Du nimmst eine Vorbildfunktion in der Prävention von Unfällen wahr und leistest deinen persönlichen Beitrag zur Sicherheit der Bevölkerung bei Arbeit und Freizeit – genauso wie weitere...
-
Mitarbeiter:in Public Affairs 60
vor 3 Wochen
Luzern, Luzern, Schweiz Suva VollzeitLuzern unbefristet Eine Aufgabe bei der Suva ist weit mehr, als einfach nur seiner Arbeit nachzugehen. Bei uns kannst du dich einbringen und Verantwortung übernehmen. Du nimmst eine Vorbildfunktion in der Prävention von Unfällen wahr und leistest deinen persönlichen Beitrag zur Sicherheit der Bevölkerung bei Arbeit und Freizeit – genauso wie weitere...
-
Patient Pathway Manager
Vor 6 Tagen
Luzern, Luzern, Schweiz MSD VollzeitOur Human Health Division maintains a "patient first, profits later" ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.We are currently seeking a Patient Pathway Manager (PPM) for our Hospital Acute...
-
Clinical Research Manager
Vor 6 Tagen
Luzern, Luzern, Schweiz MSD VollzeitWe 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...
-
Patient Pathway Manager
vor 3 Wochen
Luzern, Schweiz MSD VollzeitOur Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide. We are currently seeking a Patient Pathway Manager (PPM) for our Hospital...
-
Marketing Manager Livestock Animal Health
vor 4 Wochen
Luzern, Schweiz MSD Vollzeit**Our Animal Health Marketing team takes a customer centric perspective using customer feedback and market intelligence data. Using this data, we design, develop and deploy products, platforms, brands and marketing initiatives that ensure we can improve the health and well-being of animals everywhere.** The Marketing Manager Livestock (M/F/d) will be...
-
Project Manager
Vor 5 Tagen
Luzern, Luzern, Schweiz WEBKINDER AG Vollzeit**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 sechzehn jungen Menschen auf. Zusammen gestalten und realisieren wir komplexe, moderne und...
