Aktuelle Jobs im Zusammenhang mit Associate Director, Regulatory Affairs Vaccines Therapeutic Group - Zug - 1849 GlaxoSmithKline Biologicals S.A.
-
Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitAbout the RoleWe are seeking a highly skilled and experienced Associate Director to lead our Global Regulatory Affairs team in the area of Precision Medicine and Digital Health. As a key member of our team, you will be responsible for developing and executing regulatory strategies to support the development and approval of precision medicine and digital...
-
Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitAbout the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at 1925 GlaxoSmithKline LLC. As a key member of our organization, you will play a critical role in ensuring the development and execution of appropriate regulatory strategies for our precision medicine and digital health assets.Key...
-
Global Regulatory Affairs Director
Vor 5 Tagen
Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitJob SummaryWe are seeking a highly skilled and experienced Global Regulatory Affairs Director to join our team at 1925 GlaxoSmithKline LLC. As a key member of our organization, you will be responsible for developing and executing regulatory strategies for our Precision Medicine and Digital Health assets.Key ResponsibilitiesDevelop and implement global...
-
Associate Director, International Medical Affairs
vor 4 Monaten
Zug, Schweiz Blueprint Medicines Vollzeit**Associate Director, International Medical Affairs Operations** Location(s): Zug, Switzerland Level of position: Associate Director Position type: office-based Reporting Line: VP Medical Affairs, International ***How will your role help us transform hope into reality?** ***This position reports into the VP of International Medical Affairs and will...
-
Regulatory Strategy Associate Director
vor 3 Monaten
Zug, Schweiz Vertex Pharmaceuticals VollzeitJob Description Associate Director Regulatory Strategy, Switzerland OVERVIEW: - We are looking for a Swiss regulatory expert for our Swiss affiliate in Zug to grow our regulatory team and to ensure Vertex establishes and implements best practices in accordance with national requirements in Switzerland - Support and contribute to local Swiss...
-
Regulatory Affairs Director
vor 1 Woche
Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitJob SummaryWe are seeking a highly skilled Associate Director to lead our global regulatory strategy for Precision Medicine and Digital Health products. As a key member of our team, you will be responsible for developing and executing regulatory strategies to ensure compliance with regional and global regulatory requirements.Key ResponsibilitiesDevelop and...
-
Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitAbout the RoleWe are seeking a highly skilled and experienced Associate Director to lead our Global Regulatory Affairs team in the area of Precision Medicine and Digital Health. As a key member of our team, you will be responsible for developing and executing regulatory strategies to support the development and approval of precision medicine and digital...
-
Associate Director RA
vor 1 Monat
Zug, Schweiz NonStop Consulting VollzeitJoin a Leading Regulatory Affairs Team! About Our Client With a diverse portfolio of iconic brands (OTC & Consumer healthcare) across 20 countries, our client operates in Australia & New Zealand, Asia, and Africa. Their team is dedicated to putting people's health first every day, and they pride themselves on their unique blend of leadership and empowerment....
-
Senior Director, Regulatory Affairs
vor 3 Wochen
Oberwil b. Zug, Schweiz Hologic VollzeitAs a leading innovator of womens' health, we at Hologic are empowering people to live healthier lives everywhere, every day, Our regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs to influence strategic and...
-
Regulatory Advertising and Promotion Lead
vor 4 Monaten
Zug, Schweiz Apellis Pharmaceuticals Vollzeit**Title: Associate Director, International Advertising and Promotion Regulatory Affairs** **Location: Zug or remote (Europe)** **Reporting: Senior Director, International Regulatory Affairs** **Description**: - The Associate Director of International Advertising and Promotion (A&P) serves as an internal expert on industry codes and guidance and...
-
Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitPurpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both...
-
Consultant - Snr Director Regulatory Affairs Eu/uk
vor 3 Monaten
Zug, Schweiz BioTalent Vollzeit**Snr Director Regulatory - Contract**: In collaboration with a well funded fast paced BioTech, BioTalent are looking to connect a seasoned Regulatory Industry professional to fulfil EU and UK requirements in alignment with the Global Team. This role will offer you - 3-6 month rolling contract - Ability to work part time - Hourly pay rate - Remote...
-
Regulatory Director for Combination Product
vor 4 Monaten
Zug, Schweiz SHL Medical AG Vollzeit**Job Overview** The position of the Director Regulatory for Combination Product, Medical Devices and Emerging Technologies is based in the HQ of SHL Medical AG in Zug. It holds overall responsibility for Regulatory matters related to combination products, medical devices and emerging technologies. The holder is responsible for establishing applicable...
-
Regulatory Affairs Manager
vor 4 Wochen
Zug, Schweiz Johnson & Johnson VollzeitJohnson & Johnson is currently seeking a Regulatory Affairs Manager to join our local Regulatory Affairs team located in Zug, Switzerland. This role will be working in a hybrid working model. We are looking for a highly motivated individual to join our team as a Regulatory Affairs Manager. In this position, you will play a crucial role in ensuring adherence...
-
Regulatory Affairs Manager
vor 1 Woche
Zug, Zug, Schweiz KMP MANAGEMENT CONSULTING VollzeitAufgaben und VerantwortlichkeitenAls Regulatory Affairs Manager sind Sie für die Einhaltung der regulatorischen Anforderungen für Medizinprodukte verantwortlich. Sie müssen sicherstellen, dass Produkte und Prozesse den neuen und existierenden regulatorischen Anforderungen entsprechen.Qualifikationen und ErfahrungenErfolgreich abgeschlossenes Studium im...
-
Regulatory Affairs Manager
Vor 6 Tagen
Zug, Zug, Schweiz KMP MANAGEMENT CONSULTING VollzeitAufgabenAls Regulatory Affairs Manager sind Sie für die Einhaltung der regulatorischen Anforderungen für Medizinprodukte verantwortlich. Sie müssen sicherstellen, dass Produkte und Prozesse den neuen und existierenden regulatorischen Anforderungen entsprechen.Identifizierung von anwendbaren regulatorischen, legalen und anderen externen Anforderungen in...
-
Regulatory Affairs Senior Manager
vor 1 Woche
Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl VollzeitAbout the RoleGilead Sciences Switzerland Sarl is seeking a highly skilled and experienced Regulatory Affairs Senior Manager to join our team in Zug, Switzerland. As a key member of our CMC Regulatory Affairs International Affiliate Team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to meet business...
-
Regulatory Affairs Specialist
vor 1 Woche
Zug, Zug, Schweiz Congo Brands VollzeitAbout Congo BrandsCongo Brands is a leading health and wellness company that offers a diverse range of supplements, fitness snacks, hydration drinks, and energy drinks through e-commerce and retail partnerships.The company houses several notable brands, including Alani Nu, Prime Hydration, Prime Energy, and 3D Energy, with plans to expand its portfolio in...
-
Senior Regulatory Affairs Manager
vor 3 Wochen
Zug, Zug, Schweiz Michael Page VollzeitAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Michael Page. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.Key ResponsibilitiesRegulatory Strategy and PlanningDevelop and...
-
European Regulatory Affairs
vor 4 Monaten
Zug, Schweiz Proclinical VollzeitProclinical are recruiting a European Regulatory Affairs - CTA Liaison for a biotech corporation. This role is on a contract basis and is located in Zug. **Responsibilities**: - Collaborate with regulatory affairs consultants/service suppliers on CTA proposals. - Serve as a representative for EU regulatory affairs at cross-functional study management team...
Associate Director, Regulatory Affairs Vaccines Therapeutic Group
vor 4 Monaten
The Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects.
The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with Asset Development Strategy /Integrated Asset plan. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labelling to meet the Asset Profile, commensurate with the available data.
Responsibilities and Accountabilities:
You are accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP (Vice Presidents) level and representing GSK with at least the local regulatory agency. Work within the larger GSK matrix organization (ie Early/Medicine/Vaccine development Team, Commercial etc) to ensure a robust Regulatory strategy is in place to support particular stage of product life cycle to secure product licensure in key markets identified in the Integrated Asset Plan as well as securing best possible labeling commensurate with the available data. Lead interactions with local / regional regulatory authorities. In performing the role, you will be responsible for:
Proactively developing regulatory strategy, considering the needs of other regions globally.
Implementation of the regional strategy(s) in support of the project globally
Lead regulatory interactions and the review processes for assigned asset strategy
Ensuring appropriate interaction with global/regional counterparts and commercial teams where applicable
Ensuring compliance with global/ regional requirements at all stages of product life cycle.
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy.
Why you?
Experience, Skills and Specialized Knowledge Required
Degree in biological or healthcare science
Experience in Early activities and launch of Phase I and II, experience of all phases of the drug development process in Regulatory Affairs preferred
Capable of leading regulatory development, submission, and approval activities in assigned region(s)
Knowledge of clinical trial and licensing requirements in all major countries (EU,US, JP, China) and ideally knowledge of other key Agency processes globally.
Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine
Competencies and Capabilities:
Good communication skills, especially written communications. Capable Skilled at delivering key communications effectively with clarity, impact, and passion
Ability to foster strong matrix working and develops strong networks. Facilitates dialogue between team and matrix members to contribute their ideas.
Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
Capable of developing and recommending strategies for change.
Capable of identifying long term project or team issues in advance and seeking necessary help and support to resolve.
Ability to take sound decisions and in doing so, will use a range of sources and weigh benefits and risks before making important decisions.
Challenges and questions ways of working to seek improved processes. Seeks to raise levels of performance by establishing or improving processes.
#LI-GSK
#GSKVaccines
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
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.
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.
