Director, Global Regulatory Affairs, Precision Medicine
vor 1 Monat
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.
Responsibilities and Accountabilities (include expected deliverables, managerial and leadership responsibilities and performance standards):
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 and representing GSK with Precision Medicine/Digital Health partners and regulatory agencies. This role works closely with members of the Experimental Medicine Unit and Digital Health teams. Lead or participate in interactions with local / regional regulatory authorities.
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.
Competencies and Capabilities (include key high performance behaviors).
Challenges and questions ways of working to seek improved process.
Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Master’s Degree in biological science, healthcare science, or engineering.
Experience in regulation of companion diagnostics and SaMD.
Led global development, submission, and approval activities. Organized and executed milestone meetings.
Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in all major countries.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
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.
#LI-GSK
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.
-
Zug, Zug, Schweiz GlaxoSmithKline VollzeitSite Name: USA - Pennsylvania - Upper Providence, GSK House, Switzerland - Zug, USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date: May PurposeEnsure 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...
-
Director, Global Regulatory Affairs, Precision
vor 3 Wochen
Zug, Schweiz GSK Vollzeit**Site Name**: USA - Pennsylvania - Upper Providence, GSK House, Switzerland - Zug, USA - Massachusetts - Waltham, USA - North Carolina - Durham **Posted Date**: May 16 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...
-
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...
-
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...
-
Associate Director, Global Regulatory Affairs
vor 2 Wochen
Zug, Schweiz GSK Vollzeit**Site Name**: USA - Pennsylvania - Upper Providence, GSK House, Switzerland - Zug, USA - Massachusetts - Waltham, USA - North Carolina - Durham **Posted Date**: May 17 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...
-
Director, Cmc Regulatory Affairs
vor 3 Wochen
Zug, Schweiz GSK Vollzeit**Site Name**: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, GSK House, Rockville Biopharm, Stevenage, UK - Hertfordshire - Ware, Waltham, Zug House **Posted Date**: Feb 22 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,...
-
Associate Director Regulatory Affairs
vor 2 Wochen
Zug, Zug, Schweiz Planet Pharma VollzeitPlanet Pharma is pleased to be working with a leading organisation to recruit for an Associate Director , Regulatory Affairs to work within consumer Health. This is a permanent position in Switzerland.The primary purpose of the position is to lead and manage the European (including the EEA, Eastern Europe, Switzerland and the UK) Regulatory Affairs strategic...
-
Associate Director Regulatory Affairs
vor 2 Wochen
Zug, Schweiz Planet Pharma VollzeitPlanet Pharma is pleased to be working with a leading organisation to recruit for an Associate Director , Regulatory Affairs to work within consumer Health. This is a permanent position in Switzerland.The primary purpose of the position is to lead and manage the European (including the EEA, Eastern Europe, Switzerland and the UK) Regulatory Affairs strategic...
-
Intern Regulatory Affairs
vor 2 Wochen
Zug, Zug, Schweiz Viatris Vollzeit7087 Mylan Pharma GmbHAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access - Providing high quality trusted medicines regardless of...
-
Associate Director, Regulatory Affairs Vaccines
Vor 3 Tagen
Zug, Schweiz GSK Vollzeit**Site Name**: Siena, GSK House, Italy - Siena, Switzerland - Zug, USA - Maryland - Rockville **Posted Date**: May 31 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...
-
Medical Director, Global Medical Affairs
Vor 5 Tagen
Zug, Schweiz GSK Vollzeit**Site Name**: UK - London - Brentford, Baar Onyx, Switzerland - Zug, USA - Pennsylvania - Upper Providence **Posted Date**: Apr 4 2024 **Medical Director, Global Medical Affairs - Hematology**: The Global Medical Director role is a unique opportunity for an experienced, innovative, and proactive medical professional to facilitate the understanding of the...
-
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...
-
Associate Manager, Regulatory Affairs
vor 2 Wochen
Zug, Zug, Schweiz Seagen VollzeitPosition Summary:The Regulatory Affairs Associate Manager will report to and support the Regulatory Affairs Director/Associate Director by leading the preparation and submissions of regulatory dossiers to European and Swiss competent authorities, in line with the global regulatory plan for one or more Oncology products.Principal Responsibilities: Provide...
-
Director, International Medical Affairs
vor 12 Stunden
Zug, Schweiz Blueprint Medicines VollzeitLocation(s): Zug,Switzerland Level of position: Director Position type: office-based Reporting Line: VP, Medical Affairs InternationalHow will your role help us transform hope into reality?The Medical Director, International Medical Affairs will be part of the international Medical Affairs team based in Switzerland, responsible for the successful preparation...
-
Consultant - Snr Director Regulatory Affairs Eu/uk
vor 2 Wochen
Zug, Zug, Schweiz BioTalent VollzeitSnr 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 36 month rolling contract Ability to work part time Hourly pay rate Remote workingYou will be...
-
Intern Regulatory Affairs
vor 4 Wochen
Zug, Schweiz Viatris Vollzeit7087 Mylan Pharma GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...
-
Associate Director, International Medical Affairs
vor 3 Wochen
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...
-
Medical Advisor Oncology
vor 4 Wochen
Zug, Schweiz Johnson & Johnson VollzeitWe are seeking a Medical Advisor Oncology (Lung Cancer) & Precision Medicine located in Switzerland: - Job purpose: - Acts as a scientific expert (internally and externally) with deep knowledge of the Therapeutic Area (TA), treatment trends incl. unmet medical needs, scientific insights and clinical studies to maximize company product value through high...
-
Zug, Schweiz 1849 GlaxoSmithKline Biologicals S.A. VollzeitThe 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...
-
Zug, Schweiz 1849 GlaxoSmithKline Biologicals S.A. VollzeitThe 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...
