Job Description

An opportunity has arisen to join the Nonclinical Regulatory affairs team. You will be responsible for the nonclinical regulatory activities in the investigational, late phase development and/or commercial lifecycle management of GSK products. It’s an exciting time to be joining the group, and this position offers an excellent opportunity to be part of a motivated and collaborative team. 

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 nonclinical regulatory activities for assigned projects and respond readily to changing events and priorities.
Be responsible for nonclinical strategy development, with managerial support, for nonclinical submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and lifecycle management activities in accordance with the applicable regulatory & scientific standards
Understand, interpret and sometimes advise teams on regulations, guidelines, procedures and policies relating to nonclinical drug development and registration, to expedite the submission, review and approval of global Nonclinical applications.
Ensure information submitted in clinical/marketing applications meets regional requirements with minimal unanticipated questions.
Work in cross-functional matrix project teams, which include colleagues from regulatory, preclinical and Clinical ensuring adequate interaction and partnership in order to define proper regulatory nonclinical filing strategy.
Maintain high quality standards and seeks 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 shares best-practices and learnings within the Nonclinical Regulatory teams and other impacted functions.
Engage in Nonclinical Subject Matter Expert activities internally (for increased compliance,?harmonisation?and efficiency)
Occasionally deliver Nonclinical regulatory strategy to support major audits with managerial support

Why you?

Basic Qualifications & Skills:

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

Bachelors degree in life science related field, or extensive experience in role
Nonclinical regulatory affairs or nonclinical drug development experience (in the fields toxicology, pharmacology, pharmacokinetics) with direct involvement in regulatory submission preparation across all stages of development through to life cycle submissions.
Sound knowledge of drug development and may have a specialized area of expertise. 
Knowledge of worldwide nonclinical regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
Good time and project 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:

Wider experience/understanding within regulatory affairs, understanding of evolving trends and policies.
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
May be identified as Nonclinical Regulatory expert in a specific subject area.
Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
Demonstrated ability to handle global nonclinical issues through continuous change and improvement
Some experience supporting major filing activities (MAA/NDA/BLA, key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development)

Closing Date for Applications – 17th September 2023 (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.