Global Regulatory Affairs Manager

Vor 5 Tagen

Baar, Schweiz GSK Vollzeit

**Site Name**: UK - London - New Oxford Street, Baar Onyx

**Posted Date**: Jun 25 2024

We are looking for a driven and motivated Global Regulatory Affairs Manager to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

**In this role you will**
- Ensure appropriate interaction with the cross-functional team, global/regional counterparts and with local operating companies
- Ensure compliance with global/ regional requirements
- Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset

**Why you?**

Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:

- Bachelor’s degree in biological or healthcare science
- Experience of the drug development process in regulatory affairs
- Capable of leading development, submission and approval activities in different region(s) globally
- Knowledge of clinical trial requirements at least in one the region (EU or US) and ideally knowledge of other key Agency processes globally.
- Ability to develop necessary specialist knowledge for the product in a specific oncology disease area

Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

- PhD in biological or healthcare science
- Ability to foster strong matrix working, facilitating dialogue between team and matrix members to contribute their ideas.
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
- Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations in all regions.
- Focus on improving performance and excellence by challenging the ways of working and capable of developing and recommending strategies for change.
- Able to develop own networks within GSK and of securing appropriate support and outcome for a project.

Closing Date for Applications - 9th July

Please take a copy of the Job Description, as this will not be available post closure of the advert.

**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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please note should your enquiry not relate to adjustme

  • Global Regulatory Affairs Manager

    vor 2 Wochen

    Baar, Schweiz GSK Vollzeit

    **Site Name**: UK - London - Brentford, Baar Onyx **Posted Date**: Mar 22 2024 Global Regulatory Affairs Manager - Oncology We are looking for a driven and motivated Global Regulatory Affairs Manager to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Baar, Schweiz Universal-Job Vollzeit

    In this role you are responsible for leading regional regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects and programs, to support commercialisation. Your accountabilities will include: - Responsible for defining Biosimilar regulatory...

  • Manager Regulatory Affairs Central Europe

    vor 1 Woche

    Baar, Zug, Schweiz Abbott Vollzeit

    Abbott is a key player in the global healthcare industry, dedicated to enhancing people's lives at every phase. With a diverse range of life-improving technologies, including diagnostics, medical devices, nutritionals, and branded generic medicines, Abbott operates in over 160 countries with the support of 115,000 colleagues.Abbott's Nutrition Division is...

  • Manager Regulatory Affairs Central Europe

    vor 4 Wochen

    Baar, Schweiz Abbott Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. ...

  • Regulatory Affairs and Vigilance Manager 100%

    Vor 2 Tagen

    Baar, Schweiz schiller Vollzeit

    Zur Verstärkung unserer Abteilung  Regulatory Affairs  suchen wir per sofort eine motivierte Persönlichkeit als Regulatory Affairs and Vigilance Manager 100% Ihre Aufgaben Auswertung von gemeldeten Vorkommnissen zur Einhaltung gesetzlicher Vorschriften der auf dem Markt befindlichen Medizinprodukte Entwicklung und Durchführung von...

  • Regulatory Affairs Manager

    vor 1 Woche

    Baar, Zug, Schweiz Medela LLC Vollzeit

    In this role you are representing regulatory in strategic new development projects across a wide product portfolio within our Mom & Baby, NICU & Maternity Care product line. It is your responsibility to raise awareness in terms of regulatory affairs matters amongst the different departments. You will enjoy interacting with a wide variety of stakeholders in...

  • Associate Director Regulatory Affairs

    vor 2 Wochen

    Baar, Schweiz Alexion Pharmaceuticals,Inc. Vollzeit

    Location: Baar, Switzerland Job reference: R-192738 Date posted: 02/21/2024 **This is what you will do**: Reporting to the Head of CENE Regulatory and Quality Affairs (RQA), this position is responsible for providing proactive strategic regulatory support and advice to the VP CENE Area Head, Head of CENE RQA and the Country Directors of the CENE region....

  • Regulatory Affairs Associate Director

    vor 4 Wochen

    Baar, Schweiz GSK Vollzeit

    **Site Name**: Belgium-Wavre, Baar Onyx, GSK House, Italy - Siena **Posted Date**: May 29 2024 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...

  • Regulatory Affairs Associate Director

    Vor 2 Tagen

    Baar, Schweiz GSK Vollzeit

    **Site Name**: Belgium-Wavre, Baar Onyx, GSK House, Italy - Siena **Posted Date**: May 29 2024 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...

  • Senior Director, Global Regulatory Strategy, Therapeutic Area Lead

    vor 1 Monat

    Baar, Schweiz Biogen Vollzeit

    Job Description About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and rare disease...

  • Senior Director, Global Regulatory Strategy, Therapeutic Area Lead

    vor 1 Woche

    Baar, Zug, Schweiz Biogen Vollzeit

    Job Description About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and rare disease...

  • Senior Director, Global Regulatory Strategy, Therapeutic Area Lead

    vor 4 Wochen

    Baar, Schweiz Biogen Vollzeit

    Job Description About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and rare disease...

  • Senior Specialist Regulatory Affairs Central Europe

    vor 2 Monaten

    Baar, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160...

  • Senior Specialist Regulatory Affairs Central Europe

    vor 2 Monaten

    Baar, Zug, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Abbott's...

  • Senior Specialist Regulatory Affairs Central Europe

    vor 4 Wochen

    Baar, Zug, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Abbott's...

  • Regulatory Affairs Associate Director

    vor 2 Wochen

    Baar, Schweiz GlaxoSmithKline Vollzeit

    Site Name: Belgium-Wavre, Baar Onyx, GSK House, Italy - SienaPosted Date: May 29 2024The 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...

  • Medical Affairs Manager

    vor 1 Woche

    Baar, Zug, Schweiz AstraZeneca Vollzeit

    Medical Affairs Manager - Lung Cancer in OncologyLocation: Baar, SwitzerlandAbout AstraZeneca:AstraZeneca is one of the global leaders in the development and commercialization of innovative drugs for oncologic patients. We strive every day to make cure a reality for the millions of people living with cancer across the world.It is through this relentless...

  • Policy & Government Affairs Lead

    vor 1 Woche

    Baar, Schweiz AstraZeneca Vollzeit

    Policy & Government Affairs Lead Location: Baar, Switzerland **About **AstraZeneca**: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading...

  • Medical Affairs Manager

    vor 1 Woche

    Baar, Zug, Schweiz AstraZeneca Vollzeit

    Medical Affairs Manager - RespiratoryAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.We are pushing the boundaries of...

  • Global Medical Affairs Lead, Hematology

    vor 2 Monaten

    Baar, Schweiz GSK Vollzeit

    **Site Name**: USA - Pennsylvania - Upper Providence, Baar Onyx, UK - London - Brentford **Posted Date**: Nov 16 2023 **Overview** Momelotinib was recently approved by the FDA, received positive CHMP opinion and expects EMA approval in the next few weeks and will be followed by multiple approvals worldwide, for treating patients with myelofibrosis that...