Non-clinical Regulatory Project Manager - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
UK - Hertfordshire - Ware RD, Belgium-Wavre, GSK House, USA - Pennsylvania - Upper Providence

Posted Date:
Aug

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.
Work in crossfunctional 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 bestpractices 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 coordinate 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
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 - 24th August 2023 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.

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.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our G