Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Senior Manager, Global Regulatory Affairs role could be an ideal opportunity to explore.
As a Senior Manager, you will manage multiple projects 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:
Why you? Basic Qualifications:
- Drive the CMC strategy, coordinate the timely preparation and author, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements.
- Be the primary point of contact with CBER for submission of variations, meeting requests and other communication.
- Maintain organizational networks within and outside GSK at the local level.
- Serve as the escalation contact for regulatory associates located in the Center.
- 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
- Extensive knowledge of drug development and manufacturing and supply processes.
- Broad and deep knowledge of worldwide regulatory requirements.
- Proven project management skills and the ability to manage and direct multiple projects
- Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues personnel in a variety of settings
- Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
- 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
- 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 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:
- 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.
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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