Regulatory Affairs Manager or Associate Director - Classic and Established Products

Job description

Nombre del sítio: UK - London - Brentford
Fecha de publicación: Feb 15 2024

Regulatory Affairs Manager / Associate Director - Classic & Established Products

We are looking for a bright and ambitious Regulatory Affairs Manager or Associate Director to ensure the development of regulatory strategy(ies) (excluding US) and their execution for assigned asset(s) consistent with the strategic activities for GSK’s Classic & Established Product (CEP) portfolio.. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate 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 conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with regulatory agencies, including directly with the European Medicines Agency and other European Local Authorities for Centralised and Mutual Recognition procedure products. Work closely with partner functions to secure best regulatory strategy to deliver commercial and supply strategies based on available  data. Work with local regulatory function to (co)- lead interactions with local / regional regulatory authorities

In this role you will

·  Ensure that the regulatory strategy delivers the needs of the Global and regional projects, while taking into account the regulatory needs of the local market(s).
·  Take ownership of multiple CEP portfolio Assets acting as Global Regulatory Lead to drive matrix team engagement.
·  Lead regulatory interactions and review processes.
·  Ensure appropriate interaction with regional and global  commercial  teams.
·  Ensure compliance with regional regulatory requirements.

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
·  Experience of all phases of the drug development process in regulatory affairs, with particular emphasis on maintenance and lifecycle management of marketed products, including for projects with little or no precedence.
·  Capable of leading regional regulatory strategy development, submission and approval activities in local region(s).
·  Extensive knowledge of licensing requirements in all major countries in the region and knowledge of other key Agency processes.
·  Capable of being able to develop product / therapeutic knowledge in new area

Preferred Qualifications & Skills:

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

·  Excellent communication skills. Capable of delivering key communications with clarity, impact and passion.
·  Ability to foster strong matrix working, facilitating dialogue between team and matrix members to contribute their ideas.
·  Brings team members into the discussion so they contribute their ideas. Capable of developing and recommending strategies for change. 
·  Developing personal networks within GSK and capable of using them to secure appropriate support and outcome for a project.
·  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. Recognizes and escalates potential long-term risks for projects/products.
·  Ability to use a range of sources and weigh benefits and risks before making important decisions.
·  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. 

Closing Date for Applications – 29th February 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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