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 Manager could be an ideal opportunity to explore.
As a Regulatory Affairs 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.
- More than 8 years of experience in regulatory affairs.
If you have the following characteristics, it would be a plus:
- Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
- Experience at a large global pharmaceutical or vaccines company
- Experience leading global teams
- Experience in managing teams and leading in a matrix organization.
- Experience with US regulatory environment.
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, rigor 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.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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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.
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