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Associate Director,/Director Global Regulatory Affairs, Precision Medicine
& Digital Health

Brentford

Job Type

Job Function

Regulatory

Location

Brentford

On-Site or Remote

Job Type

Salary

Competitive salary and benefits

About the Role

*Job description* *Site Name:* USA - Pennsylvania - Upper Providence, UK - London - Brentford *Posted Date:* Jan 30 2024 Are you a Regulatory Affairs professional looking to expand your career in Precision Medicine and Digital Health? If yes, then this Associate Director/Director role may be for you! 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. *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. • Three or more years of experience in regulatory consideration for all phases of the companion diagnostics and/or SaMD, including for projects with little or no precedence. • Three or more years of experience of leading global development, submission and approval activities. • Three or more years of experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in all 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. · Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority. · 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 make 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. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. *Why Us?* 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

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