Regulatory Affairs Project Manager

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, harmonisation and 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 Applica