- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines and expectations for submissions.
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines and managing multiple submissions simultaneously
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
- Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
- Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
- Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
- Proven ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Accountable to GRL/ Regional Rep/ C&EP lead for delivery of submissions or strategy components for an assigned product in development or marketed product; planning own and submission team activities to ensure delivery to agreed timeframes and appropriate content
- Responsible for the implementation of the submission strategy for TG supported markets
- Responsible for the development and implementation of the submission strategy for NCE Global Delivery supported markets
- Ensures quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role.
- Works 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.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
- May be part of the Regulatory Matrix Team for the given product and accountable for leadership of relevant submission team.
- May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc
Who Are We - GSK?
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc , although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies.Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.Our values and expectations are at the heart of everything we do and form an important part of our culture:
Our values are Patient focus, Transparency, Respect, Integrity