Regulatory Project Manager, Open to flexibility
Regulatory Project Manager, Open to flexibility
A new opportunity for a Regulatory Project Manager to join our pharma business at Stockley Park, UK. You will get to work on exciting projects that help GSK contribute to our mission of helping people Do More, Feel Better and Live Longer.
To ensure that appropriate content for a range of submissions is developed to agreed timeframes.
This role will require leadership of submission teams for a range of applications potentially including clinical sections to NCE files and CTA's / together with a range of submissions required to maintain existing product licenses in Europe and APJEM
The individual will take full accountability of all aspects of the assigned tasks in support of an overall project including ensuring full compliance with GSK process and policy as they apply to the role.
Responsibilities and Accountabilities (include expected deliverables, managerial and leadership responsibilities and performance standards)
Reporting to the Director/Sr Director Regulatory Practice/TG, the job holder is accountable for delivery of assigned submissions, file or strategy components under supervision of GRL/Regional Representative/Line Manager. Within this supervision, plans own, and submission team, activities to ensure delivery. May be part of the Regulatory Matrix Team for the given asset and accountable for leadership of relevant submission team. The job holder will work with staff from other functions, and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues. In performing this role the job holder:
- Will take primary responsibility is for leadership of, preparation and review of day to day submissions with full accountability for delivery.
- May also take accountability for larger submissions as part of an overall project plan i.e. line extensions, major components of a submission of a NCE, major responses etc
- May, working with GRL/RR/Manager, develop components of regulatory strategy for a region.
- Ensures quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines.
- May be required to liaise with Regulatory Agencies to resolve straight forward issues in relation to their accountabilities.
- May be responsible for the implementation of the submission strategy (Waves 1, 2 and 3) with APJEM for an assigned marketed product or product in development.
- May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonisation etc
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Thank you for your interest in this opportunity.
Closing date: 9am GMT 23rd October
- Bachelor degree or preferably PhD in biological or healthcare science
- Knowledge of the drug development process
- Knowledge of regulatory agency guidelines and expectations for submissions and ability to interpret as required
- Knowledge of regulatory agency review processes globally for both marketing applications and clinical trial applications.
- Must be capable of working flexibly across areas of medicines and teams, potentially managing multiple submissions simultaneously
- Able to make judgements and take one off actions to meet specific project need or solving immediate problem while balancing competing calls on time.
- Sound interpersonal skills
- Involves people in issues that affects them, facilitates dialogue between team members so they understand the links between their different ideas and perspectives. Brings team members into discussion so they can contribute their own ideas
- Sound problem solving skills
- Uses a range of sources and methods to obtain information relevant to a particular task or activity. Aware of the value of new ideas and open to ideas put forward by others
- Proven communication skills, especially written
- Communicating with others in a manner which is clear, concise, well structured, authentic and easily understood
- Ability to interpret and advise on guidelines and requirements on a global basis
- Aware of guidelines and requirements for licensing and clinical trials and able to reflect recent GSK experience in advising submission teams
- Ability to lead submission teams and network in a matrix environment effectively
- Ability to build effective working relationships
- Aims to see issues through the "eyes of another". Being non-evaluative and non-judgemental about understanding the views of others, even when this view conflicts with own.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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