Manager/Associate Director, Therapeutic Group, Global Regulatory Affairs
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Jul 9 2020
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.
- Minimum of two years prior 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 in managing teams and leading in a matrix organization.
- Experience with US regulatory environment.
- Experience at a large global pharmaceutical or vaccines company
- Experience leading global teams
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:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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.
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