Sr Manager, Global regulatory affairs
Site Name: USA - Maryland - Rockville, Belgium-Wavre, Italy - Siena, Philadelphia Navy Yard, UK - United Kingdom
Posted Date: Mar 9 2023
Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.
As Regulatory Affairs Operations Manager, you will manage multiple projects and teams simultaneously and will provide assessments (metrics, data) and conclusions/action plans within and across departments. You’ll identify risks associated with submission data and information packages, and lead in the creation, maintenance and continuous improvement of Regulatory processes, policies and systems.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
You will maintain organizational networks within and outside GSK at local level (e.g., maintains relations with Local site leadership).
Serve as the escalation contact for regulatory associates located in the Center.
You will recruit, lead and motivate staff within and across teams on assigned tasks for global teams.
Be responsible for identifying and escalating (as appropriate) risks associated with regulatory deliverables
Based on strategy from the regional team customer groups, ensure all appropriate regulatory aspects for product release are in place, to ensure continuity of market supply.
Ensure information submitted in marketing applications meets regional requirements, allowing maximum GSK flexibility with minimal unanticipated questions.
Establish and maintain networks with the Global Regulatory Affairs customer groups
Monitor and react to key performance indicators for the Center.
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in life sciences or related scientific discipline
5+ years experience with drug development and manufacturing and supply processes.
5+ years experience with regards to worldwide regulatory requirements.
5+ years experience in project management skills and the ability to manage and direct multiple projects
5+ years Line management experience
If you have the following characteristics, it would be a plus:
Master’s degree or doctorate in life sciences or related scientific discipline
5+ years working with, influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues personnel in a variety of settings
5+ years' experience handling complex global CMC issues through continuous change and improvement.
Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines marketed product support.
Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
Broad knowledge base across regulatory functions.
Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings.
Our values and expectations are 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:
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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