Regulatory Manager- Established Products, Open to flexible working
Ensure the development of regulatory strategy(s) (excluding US) and their execution for assigned asset(s) consistent with the strategic activities for GSK's Classic & Established Product (CEP) portfolio. Ensure compliance with both internal GSK process / policy and with regional regulatory requirements.
Reporting to the Senior Director Therapeutic Group CEP.
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 for centralised approved products. Work closely with partner functions to secure / maintain best possible labelling commensurate with the available data. Work with local regulatory function to (co)- lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for:
- Ensuring the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
- Implementation of the regional strategy(s) in support of the project globally
- Lead regulatory interactions and the review processes
- Ensuring appropriate interaction with regional and CEP commercial teams
- Ensuring compliance with regional regulatory requirements
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
If you have the following characteristics, it would be a plus:
- Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion
- Able to foster strong matrix working. Involves people in issues that affect them. Facilitates dialogue between team and matrix members so they understand links between their different 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 propose creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognises and escalates potential long-term issues for projects/products
- Ability to take sound decisions. In doing so use a range of sources and weigh benefits and risks before making important decisions, seeking support and endorsement as necessary.
- Shows a consistent focus on compliance and seeking to deliver and perform with 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
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