Regulatory Project Manager

Site Name: UK - London - New Oxford Street, Durham Blackwell Street
Posted Date: Jul

We are seeking a highly motivated Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Group. Within Global Regulatory Affairs, the CMC organisation provides regulatory leadership to CMC teams encompassing Global Supply Chain (GSC), Technical and Quality representatives and Local Operating Companies to enable an uninterrupted supply of our medicines to patients. Our work spans all formulation types and markets for marketed small molecules.

We currently have an excellent opportunity to work on exciting projects as well as influence and shape new ways of working. As Regulatory Project Manager (CMC), you will be responsible for the provision of CMC support to a defined portfolio of marketed drug substances and products (small molecules) for global markets. This is an interesting and fast paced role which will provide opportunity for you to use and develop your CMC technical skills and regulatory knowledge for all regulatory active countries.

Key responsibilities include maintenance of the global regulatory information for assigned products by leading CMC Regulatory Matrix teams and representing CMC in the cross-functional Regulatory Matrix Teams. In delivering your objectives you will partner with the manufacturing organisation (both Technical and Quality) to provide strategic regulatory advice for change controls, develop regulatory strategies and plans (through to implementation), and lead authoring of the variation dossiers and responses to Regulatory Agency questions.

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

• Develop CMC strategy for CMC submission documents to support small molecule marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
• Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products
• Ensure all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply.
• Ensure information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
• Maintain high quality standards, seeking to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Ensure regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions.

Why you?

Basic Qualifications & Skills:

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

• BSc or equivalent within a relevant subject such as pharmacy, chemistry, or a related scientific discipline.
• Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience.
• Direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions.
• Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
• Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products.
• Strong time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.

Preferred Qualifications & Skills:

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

• MSc within a relevant subject such as pharmacy, chemistry, or a related scientific discipline
• Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
• Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
• Strong interpersonal, presentation and communication skills.
• Demonstrated ability to handle global CMC issues through continuous change and improvement.
• Strong project management skills.

Closing Date for Applications - 30 July 2024 (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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