Regulatory Manager/Associate Director - Therapeutic Groups

Job description

Nombre del sítio: UK - London - Brentford
Fecha de publicación: Feb 23 2024

390228 Regulatory Manager/Associate Director

We are looking for a talented Manager/Associate Director with strong global regulatory affairs knowledge/experience and interpersonal skills to join our GSK Specialty Therapeutic Group, Global Regulatory Affairs team.

 As a valued member of the Regulatory Matrix team and the asset project teams, you will be empowered to develop appropriate regional regulatory strategy(s) and ensure their execution for assigned assets, consistent with the Medicines Development Strategy. With your strong regulatory expertise and communication/negotiation skills, you will provide regulatory strategic leadership and support for assigned asset(s) in the Pharmaceutical R&D portfolio and life cycle management, for regions outside US, with focus in EU, China, Japan and Emerging Markets.

You will ensure the development of appropriate regional regulatory strategy and its execution for assigned asset(s) consistent with the Medicines Development Strategy. This goal to be achieved as a component of an overall global regulatory approach, ensuring compliance with both internal GSK process/policy and with regional regulatory requirements.

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

·  Lead interactions with local/regional regulatory authorities.
·  Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. 
·  Implement the regional strategy(s), and lead regulatory interactions and the review processes in the local region
·  Ensure appropriate interaction with global/regional counterparts and commercial teams in the local region
·  Ensure compliance with global/ regional requirements at all stages of product life
·  Ideally 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
·  Work closely with the local/regional commercial team (s) to secure the best possible labelling commensurate with the available data.

Why you?

Basic Qualifications & Skills:

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

·   Bachelor’s degree or preferably PhD in biological or healthcare science
·  Capable of leading regional development, submission and approval activities in local region(s)
·  Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally. 
·  Ability to make sound decisions and in doing so, the job holder will use a range of sources, and weigh benefits and risks, before making important decisions. Demonstrate a constant focus on improving performance and excellence in all tasks.  Challenges and questions ways of working to seek improved process.  Seeks to raise levels of performance by establishing or improving process
·  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 regulation in all regions.  Ability to recognise potential long-term issues for projects.

Preferred Qualifications & Skills:

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

·  Experience of all phases of the drug development process in regulatory affairs preferred 
·  Good communication skills, especially in writing.  Capable of delivering key communications with clarity, impact, and passion
·  Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine
·  Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly
·  Ability to foster strong matrix working.  Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change. 
·  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 regulation in all regions.  Ability to recognise potential long-term issues for projects.

Closing Date for Applications – 10th March 2024 (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.

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