Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore.
As a Regulatory Affairs Management Manager, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Ensure cross portfolio aligned regulatory strategy to assure timely approvals for all US submissions.
- Facilitate integration of US-based individuals within portfolio group and integration of US-specific regulatory aspects into projects in general within the portfolio.
- Managerial responsibilities for US-based individuals within a specific Global Regulatory Affairs (GRA) project/portfolio, advice for US specific activities/processes, ensure appropriate training of US-based staff, and issue escalation.
- Ensure quality and process improvement within US and provide cross portfolio resources support as appropriate.
- Provide advice on US-specific activities and ways of working, processes as mentor or coach; in this role, provide support, as needed, for meetings/teleconferences with US regulatory agency.
- Ensure the training of US-based personnel, and ensure completeness of training curriculum, in compliance with Corporate Integrity Agreement (CIA).
- Ensure that regional strategic input is provided into Regulatory Affairs project strategy and escalation as appropriate.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
- More than 8 years of experience in regulatory affairs, with specific experience with US regulatory environment
- 8+ years' Experience in managing teams and leading in a matrix organization.
If you have the following characteristics, it would be a plus:
- Experience at a large global pharmaceutical or vaccines company
- Experience leading global teams
- A good understanding of drug development processes and strategies, with proven ability to apply innovative statistical thinking to meet project and/or business objectives
- PhD degree in a quantitative discipline such as epidemiology, health economics, health services research, health informatics, or biostatistics
- Prior experience working in oncology within the pharmaceutical/biotech industry (preferably in real-world evidence, epidemiology, or health outcomes functional areas)
- 5+ years of experience working with RWD for use in pharmacoepidemiology research with good practical knowledge in biostatistics applied to clinical/epidemiological research
- Excellent problem-solving and analytical skills and enjoy finding efficient and innovative solutions to challenging problems
- Self-reliant with the ability to deliver robust, timely, high-quality analytics
- Fluent in written and spoken English with the ability to effectively communicate and able to articulate complex concepts to diverse audiences, demonstrated throughout the interview process
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
*This is a job description to aide in the job posting, but does not include all job evaluation details.
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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