We are looking for an ambitious Regulatory Project Manager to ensure the development of regulatory strategies and their execution for assigned asset(s) consistent with the strategic activities for GSK’s Classic & Established Product (CEP) portfolio. This goal must be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

• Act as Global Regulatory Lead to drive matrix team engagement for a range of CEP portfolio Assets and take ownership of for the life cycle maintenance, including discontinuation of Marketing Authorizations (MAs), including.
• Lead communication with regulatory agencies, specifically be the main point of contact with the European Medicines Agency and other European Local Health Authorities for National, Centralised and Mutual Recognition procedures products.
• Ensure that the regulatory strategy delivers the needs of the Global and regional commercial and supply chain projects, while considering the regulatory needs of the local market(s).
• Cultivate and sustain productive relationships with internal stakeholders, including regulatory labelling, CMC, medical, commercial, supply chain, and clinical teams.
• Take proactive initiatives, demonstrating a keen ability to identify and escalate crucial issues early and actively contribute to crafting solutions.
• Ensure compliance with global/regional regulatory life-cycle requirements (e.g. renewals, label updates, aggregate safety reports etc) and delivery of health authority commitments.

Why you?

Basic Qualifications & Skills:

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

• BSc in Biological or Healthcare Science or equivalent
• Experience of all phases of the drug development process in regulatory affairs, with particular emphasis on maintenance and lifecycle management of marketed products
• In depth understanding and practical experience of European Regulatory landscape and procedural requirements, guidelines and working practices is a must.
• Knowledge of licensing requirements in other regions (APAC, LATAM, MENA) and experience with such Agencies is desirable.
• Capable of being able to develop product / therapeutic knowledge in new area.
• Ability to work in a complex environment.
• Good communication and influencing skills. Capable of delivering key communications with clarity, impact and passion.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Ability to foster strong matrix working, facilitating dialogue between team and matrix members to contribute their ideas especially working remotely and in a virtual context with stakeholders.
• Developing personal networks within GSK and capable of using them to secure appropriate support and outcome for a project.
• Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
• Ability to use a range of sources and weigh benefits and risks before making important decisions.
• Focus on improving performance and excellence by challenging the ways of working and capable of developing and recommending strategies for change.
• Has understanding of regulatory governance, medical and safety.

Closing Date for Applications – 28 Jan 2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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.

Find out more:

Our approach to R&D.

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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