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UK - London - New Oxford Street, Belgium-Wavre, Poznan Grunwaldzka, Switzerland - Zug, UK - Hertfordshire - Stevenage Posted Date:
Jan 30 2025
We are seeking an Associate Director, Global Regulatory Affairs (GRA) Precision Medicine & Digital Health to ensure the development and execution of Precision Medicine and Digital Health regulatory strategies for assigned assets across GSK therapeutic portfolio. This role ensures compliance with internal GSK processes, policies, and regional regulatory requirements to deliver the best possible labelling based on available data.
The successful candidate will work on a multi-year planning horizon, requiring extensive matrix collaboration within GSK up to the VP level. Additionally, this role involves representing GSK in regulatory discussions with partners and agencies, building and maintaining a robust team portfolio, and driving innovation in regulatory practices.
In this role you will
Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategies and their execution for assigned precision medicine and digital health assets. Lead regulatory interactions and review processes, ensuring compliance at all stages of product life from C2MD. Collaborate closely with Regulatory Operations, Precision Medicine, and Digital Health teams. Represent GSK in regulatory discussions with partners and agencies. Assess Precision Medicine and Digital Health components leveraged for potential in-license molecules. Advocate for regulatory approaches to senior leaders within GSK and Health Authorities.
Why you?
Basic Qualifications & Skills: BS in biological science, healthcare science, or engineering. Experience in regulation of in vitro diagnostics, companion diagnostics, and/or SaMD within a pharmaceutical company in at least one major market. Led global development, submission, and approval activities, including milestone meetings with Health Authorities. Demonstrated experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in at least one major market.
Preferred Qualifications & Skills: MS or PhD in a biological science, healthcare science, or engineering. Excellent communication skills, both written and verbal, with the ability to deliver impactful messages. Proven ability to build strong personal networks and facilitate collaborative solutions. Experience in leading change, resolving conflicts, and making informed decisions under time constraints. Creative problem-solving skills with a proactive approach to regulatory challenges while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
Closing Date for Applications - 13 Feb 2025 (COB)
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. 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.
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.
#J-18808-Ljbffr
UK - London - New Oxford Street, Belgium-Wavre, Poznan Grunwaldzka, Switzerland - Zug, UK - Hertfordshire - Stevenage Posted Date:
Jan 30 2025
We are seeking an Associate Director, Global Regulatory Affairs (GRA) Precision Medicine & Digital Health to ensure the development and execution of Precision Medicine and Digital Health regulatory strategies for assigned assets across GSK therapeutic portfolio. This role ensures compliance with internal GSK processes, policies, and regional regulatory requirements to deliver the best possible labelling based on available data.
The successful candidate will work on a multi-year planning horizon, requiring extensive matrix collaboration within GSK up to the VP level. Additionally, this role involves representing GSK in regulatory discussions with partners and agencies, building and maintaining a robust team portfolio, and driving innovation in regulatory practices.
In this role you will
Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategies and their execution for assigned precision medicine and digital health assets. Lead regulatory interactions and review processes, ensuring compliance at all stages of product life from C2MD. Collaborate closely with Regulatory Operations, Precision Medicine, and Digital Health teams. Represent GSK in regulatory discussions with partners and agencies. Assess Precision Medicine and Digital Health components leveraged for potential in-license molecules. Advocate for regulatory approaches to senior leaders within GSK and Health Authorities.
Why you?
Basic Qualifications & Skills: BS in biological science, healthcare science, or engineering. Experience in regulation of in vitro diagnostics, companion diagnostics, and/or SaMD within a pharmaceutical company in at least one major market. Led global development, submission, and approval activities, including milestone meetings with Health Authorities. Demonstrated experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in at least one major market.
Preferred Qualifications & Skills: MS or PhD in a biological science, healthcare science, or engineering. Excellent communication skills, both written and verbal, with the ability to deliver impactful messages. Proven ability to build strong personal networks and facilitate collaborative solutions. Experience in leading change, resolving conflicts, and making informed decisions under time constraints. Creative problem-solving skills with a proactive approach to regulatory challenges while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
Closing Date for Applications - 13 Feb 2025 (COB)
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. 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.
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.
#J-18808-Ljbffr
