Reference #: 405602 Site Name: Belgium-Wavre, Italy - Siena, UK - London - New Oxford Street, USA - Massachusetts - Boston, USA - Pennsylvania - Upper Providence Posted Date: Oct 25 2024

The CMC Development Projects Regulatory Project Manager is responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

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;

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;

Ensure regulatory compliance is maintained and shares 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:

Master's Degree in Life sciences or related scientific discipline Regulatory Affairs Certification (RAPS)

Chemistry, Manufacturing and Controls (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 quality control 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.

Good 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.

Fluency in English (written and spoken)

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

Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.

Strong interpersonal, presentation and communication skills with established internal networks

Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.

Demonstrated ability to handle global CMC issues through continuous change and improvement

Previous experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development.)

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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK? Uniting science, technology and talent to get ahead of disease t gether.

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.

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