Director, Global Regulatory Affairs, Precision

vor 3 Monaten

Baar, Schweiz GSK Vollzeit

**Site Name**: UK - London - New Oxford Street, Baar Onyx, Belgium-Wavre
**Posted Date**: Sep 25 2024

**Purpose**:
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 internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data and in the global regulatory context.

**Responsibilities and Accountabilities**:
Accountable to GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. In this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level. This role works closely with members of the Precision Medicine and Digital Health teams. This role will also have significant collaboration with the regional regulatory affiliates in the creation of a regional collaboration framework for Precision Medicine & Digital Technologies.

In performing the role, the job holder will be responsible for:

- Ensure the development of appropriate global 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. Leading regulatory interactions and the review processes for GSK.
- Ensuring compliance with regulatory requirements at all stages of product life from C2MD.
- Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities.
- Capable of providing assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules.

***:
**_Why you?_**:** Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- Bachelor’s degree in biological or healthcare science.
- Extensive experience in regulatory consideration for all phases of the companion diagnostics and/or SaMD, including for projects with little or no precedence.
- Experience of leading global development, submission and approval activities (FDA).
- Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority, additional experience ex US and EU preferred.
- Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in major countries and ideally sound knowledge globally.

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- PhD in a biological or healthcare science.
- Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques. Proven ability to foster strong matrix working. Capable of facilitating groups of individuals to work together on creating solutions. Ability to lead change and communicate difficult messages. Able to implement plans and hold self and team accountable for delivery of short and medium term goals.
- Proven ability to build strong personal networks, within GSK and use them to secure appropriate support and outcome for a project, developing an external network.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome. Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
- Proven ability to take sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints. In doing so, the job holder will use all available sources of information and weight benefits and risks before making important decisions.

**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 therape

  • Global Regulatory Affairs Director

    vor 2 Monaten

    Baar, Schweiz GSK Vollzeit

    Site Name: GSK HQ, Baar Onyx, UK - Hertfordshire - Stevenage Posted Date: Nov 15 2024 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. Are you...

  • Global Regulatory Affairs Director

    vor 2 Monaten

    Baar, Schweiz GSK Vollzeit

    **Site Name**: GSK HQ, Baar Onyx, UK - Hertfordshire - Stevenage **Posted Date**: Nov 15 2024 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...

  • Director, Regulatory Affairs Cmc

    vor 2 Monaten

    Baar, Schweiz GSK Vollzeit

    **Site Name**: UK - London - New Oxford Street, Baar Onyx, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence **Posted Date**: Nov 18 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this **Director of Regulatory Affairs, CMC **could be an exciting...

  • Global Corporate Affairs Operation Director

    vor 3 Wochen

    Baar, Schweiz Medison Pharma Vollzeit

    Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. - As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring...

  • Global Corporate Affairs Operation Director

    vor 2 Wochen

    Baar, Schweiz Medison group Vollzeit

    Switzerland · Full-timeAbout The PositionMedison offers hope to patients suffering from rare and severe diseases, by formingpartnershipswithemerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead,...

  • Regulatory Affairs Manager

    Vor 5 Tagen

    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...

  • Associate Director, Global Regulatory Cmc

    Vor 7 Tagen

    Baar, Schweiz Biogen Vollzeit

    Job Description** About This Role** This global role is responsible for development and implementation of a consistent regulatory CMC compliance framework for Global Regulatory CMC commercial products. This will include working with a broad range of stakeholders to set and monitor internal standards and policies relating to compliance while staying abreast...

  • Regulatory Affairs Manager

    Vor 5 Tagen

    Baar, 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...

  • Global Director Scientific Partnerships, Oncology

    vor 1 Tag

    Baar, Schweiz AstraZeneca Vollzeit

    **Global Director Scientific Partnerships, GMA, Oncology Business Unit** **Field based Europe role (based from an EU5 market or Switzerland)** Join our globally-renowned Oncology area, which is leading the rapid business growth of our enterprise and ever-evolving industry. It’s an exciting time to join as we work towards our big ambitions with...

  • Director of Oncology Government Affairs and Policy

    vor 7 Monaten

    Baar, Schweiz AstraZeneca Vollzeit

    **About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...

  • Regulatory Affairs Manager, Oncology Therapeutic

    vor 4 Monaten

    Baar, Schweiz GSK Vollzeit

    **Site Name**: UK - London - New Oxford Street, Baar Onyx **Posted Date**: Sep 23 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...

  • Global Medical Director, Lupus

    vor 7 Monaten

    Baar, Schweiz Biogen Vollzeit

    **Job Description** Medical Director Global Medical Affairs, Lupus** Location: Baar, Switzerland ( working as per our local hybrid HR policy) **About This Role** As Global Medical Affairs Director, Lupus you will be a strategic partner providing expert medical leadership to guide development, launch planning, and support for Lupus pipeline products to...

  • Associate Director, Oncology Therapeutic Group

    Vor 3 Tagen

    Baar, Schweiz GlaxoSmithKline Vollzeit

    Site Name: UK – London – New Oxford Street, Baar Onyx, UK - Hertfordshire - StevenagePosted Date: Dec 3 2024At 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...

  • Associate Director, Oncology Therapeutic Group

    vor 22 Stunden

    Baar, Schweiz GSK Vollzeit

    Site Name: UK – London – New Oxford Street, Baar Onyx, UK - Hertfordshire - StevenagePosted Date: Dec 3 2024At 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...

  • Policy & Government Affairs Lead

    vor 7 Monaten

    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...

  • Associate Director, Oncology Therapeutic Group

    vor 2 Monaten

    Baar, Schweiz GSK Vollzeit

    **Site Name**: UK - London - New Oxford Street, Baar Onyx, UK - Hertfordshire - Stevenage **Posted Date**: Nov 15 2024 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...

  • Oncology Medical Affairs Head, Switzerland

    vor 7 Monaten

    Baar, Schweiz AstraZeneca Vollzeit

    **Position**:Oncology Medical Affairs Head, Switzerland** **Location: Baar, Switzerland** **BACKGROUND**: OBU EUCAN is a key contributor to the continued and future growth of our Oncology business at AstraZeneca. We seek dedicated commercial leadership for our franchises across functions and markets, maximizing the regional potential of our leading...

  • Medical Director, European Partner Markets

    vor 7 Monaten

    Baar, Schweiz Medison Pharma Vollzeit

    Medison is a rapidly growing global pharmaceutical company with a strong global presence, operating in 4 continents and over 24 countries. Our mission is to provide access to highly innovative therapies to patients who suffers mainly from rare diseases, in international markets. If you are passionate about making a difference and want to be part of our...

  • Medical Affairs Manager Cardiovascular

    Vor 5 Tagen

    Baar, Schweiz AstraZeneca Vollzeit

    **Position: Medical Affairs Manager, Cardiovascular (100% FTE)** **Location: Baar, Switzerland** **Competitive Salary & Excellent Company Benefits** **About AstraZeneca** **AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of...

  • Oncology Medical Affairs Head Switzerland

    Vor 6 Tagen

    Baar, Schweiz AstraZeneca Vollzeit

    **Position**:Oncology Medical Affairs Head (OMAH)** **Location: Baar, Switzerland** **WHY JOINING ASTRAZENECA OBU?** **_ Disrupt to redefine cancer treatment_** - We’re all here to make an impact - to achieve our bold ambition of eliminating cancer as a cause of death._ - In the Oncology Business Unit, we relentlessly follow the science, challenging the...