CMC Regulatory Affairs Project Manager

Site Name: UK – Hertfordshire – Ware RD, Durham Blackwell Street, UK – London – New Oxford Street, USA – Massachusetts – Waltham, USA – Pennsylvania – Upper Providence Posted Date: Dec 10 2024 Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Chemistry, Manufacturing and Controls (CMC) Development Projects Regulatory Project Manager role could be an ideal opportunity to explore. As CMC Development Projects Regulatory Project Manager you will be responsible for the CMC regulatory activities in the in the investigational, late phase development and/or early commercial lifecycle management of Small Molecule GSK products. You will work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy. You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment. 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 Be responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities. Be responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with the applicable regulatory & scientific standards Understand, interpret and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the submission, review and approval of global CMC applications. Ensure all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensure information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions. Ensure regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions. Engage in CMC Subject Matter Expert activities internally (for increased compliance,harmonisationand efficiency) Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: BSc or equivalent in chemistry, pharmacy or related scientific discipline CMC Regulatory Affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions. Sound knowledge of drug development / manufacturing processes 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 new medicines in development. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Master’s degree in life sciences or related scientific discipline; Regulatory Affairs Certification (RAPS) Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings. Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy. Good time-management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines. Strong verbal and written communication skills with good attention to detail. Excellent team working abilities. Closing Date for Applications – 16 Dec 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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