Director, Regulatory Affairs, Precision Medicine Digital Health

Glaxosmithkline; Durham (NC); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Health care and other insurance

Retirement benefits

Paid holidays

Vacation

Paid caregiver/parental and medical/

Job summary

GSK in the United States is seeking a senior regulatory professional to develop and execute regulatory strategies for precision medicine and digital health assets across the therapeutic portfolio. This hybrid role includes leadership of regional regulatory plans, coordination with global teams, and regular interactions with health authorities to secure timely submissions and approvals.

Candidates should have 5+ years of global regulatory experience, a biology/healthcare degree (PhD preferred),

Qualifications

• Bachelor's degree in biological or healthcare science.
• 5+ years experience in regulatory consideration for all phases of companion diagnostics and/or SaMD.
• Experience leading global development, submission and approval activities (FDA).
• Ability to advocate persuasively to senior leaders and health authorities.
• Experience with clinical trial and licensing requirements for precision medicine and digital health products.

Responsibilities

• Develop global regulatory strategy(s) for Precision Medicine and Digital Health assets across the portfolio.
• Lead regulatory interactions and review processes for GSK.
• Ensure compliance with regulatory requirements at all stages of product life from C2MD.
• Collaborate with regional affiliates to create regional collaboration frameworks.

Skills

Regulatory leadership

Global regulatory experience

Cross-functional collaboration

Communication skills

Strategic planning

Education

Bachelor's degree in biological or healthcare science

Job description

Business Introduction

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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Find out more:
Our approach to R&D

Job 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.

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in biological or healthcare science.
• 5+ years 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.

Work Arrangement

This role is hybrid, based in the United States. Regular attendance at a GSK site for leadership meetings is expected. Candidates open to remote work within the U.S. may be considered if they can travel as needed.

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Resource Management, Stakeholder Management* If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $171,750 to $286,250. * If you are based in another US location, the annual base salary range is $171,750 to $286,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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