Regulatory Affairs Manager, Oncology Therapeutic Group, Global Regulatory Affairs
Date de publication :
23 septembre 2024Taux d'activité :
100%- Lieu de travail :GSK HQ
We are looking for a driven and motivated Global Regulatory Affairs Manager to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile.
You will be accountable to the GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery of clinical trial applications and approvals according to plans. The role requires extensive matrix working within GSK cross-functionally as well as with affiliates globally, as well as representing GSK with the EMA. You will work with the Clinical Development Team and with the global regulatory and regional leads, to ensure a robust regulatory strategy is in place to support the timely submission and approval of clinical trial applications in key markets.
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…
- Proactively develop and implement regulatory strategies that will deliver submission and approval of clinical trial applications according to agreed timescales
- Ensure appropriate interaction with the cross-functional team, global/regional counterparts and with local operating companies
- Ensure compliance with global/ regional requirements
- Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in biological or healthcare science
- Experience of the drug development process in regulatory affairs
- Capable of leading development, submission and approval activities in different region(s) globally
- Knowledge of clinical trial requirements at least in one the region (EU or US) and ideally knowledge of other key Agency processes globally.
- Ability to develop necessary specialist knowledge for the product in a specific oncology disease area
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
- PhD in biological or healthcare science
- Ability to foster strong matrix working, facilitating dialogue between team and matrix members to contribute their ideas.
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
- Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations in all regions.
- Focus on improving performance and excellence by challenging the ways of working and capable of developing and recommending strategies for change.
- Able to develop own networks within GSK and of securing appropriate support and outcome for a project.
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.
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