Associate Director, Global Regulatory Affairs Companion Diagnostics & Digital Health

The role will have two main responsibilities: First,  provide regulatory support for in vitro diagnostics, companion diagnostics and software as medical device with increasing scope and complexity over time. 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.

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.

Responsibility of this role will further support the GRA PMDH team by providing efficient project management support such as portfolio management, tracking of strategic internal and external initiatives, and analysis & evaluation of organization performance metrics.

This role works closely with members of the Regulatory Operations, Precision Medicine, and Unit Digital Health teams. Lead or participate in interactions with local / regional regulatory authorities.

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

• Support 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

• Create team project tracking mechanisms to facilitate resource prioritization and KPI assessment

• 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:

• BS in biological science, healthcare science, or engineering.

• Project Management Experience

• Experience in regulation of in vitro diagnostics, companion diagnostics and/or SaMD within a pharmaceutical company in at least one major market

• Demonstrated experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products at least one major market.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• MS or PhD in a biological science, healthcare science or engineering

• 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?

We offer:

• Career at one of the leading global healthcare companies

• Contract of employment

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

• Life insurance and pension plan

• Company Car

• Private medical package with additional preventive healthcare services for employees and their eligible counterparts

• Long term incentives

• Sports cards (Multisport)

• Possibilities of development within the role and company’s structure

• Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits everyday

• Free car and bike parking, locker rooms and showers

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ([email protected]) to further discuss this today.

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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/Affirmative Action Employer. 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.

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