Are you ready to make a significant impact in the world of regulatory affairs? As a Submission Lead at GSK, you'll be at the heart of our mission, working closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams, and Local Operating Company regulatory contacts. Your role will be crucial in delivering end-to-end submissions within agreed timelines, ensuring compliance with Regulatory Authority regulations and guidelines, and adhering to GSK's SOPs and working practices.
In this dynamic position, you'll also have the opportunity to mentor, coach, and train other team members, reviewing their work to guarantee right-first-time submissions. If you're passionate about regulatory excellence and thrive in a collaborative environment, we want to hear from you!
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices
- May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, label harmonization, periodic benefit risk evaluation reports (PBRER) submissions etc.)
- May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
- May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
- May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets
- May be required to lead or participate to process improvement initiatives
- May be required to take on additional Project Management responsibilities if identified as Single Point of Contact (SPOC) for the GRL.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment
- Comprehensive understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- In-depth knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV.
- Skilled in interpreting regulations and gaining consensus on a way forward in environments with multiple successful outcomes.
- Effective at interacting with line and middle management, staff, and external contacts on both functional and strategic levels in a matrix environment.
- Flexible thinker capable of meeting constantly shifting priorities and timelines.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Advanced degree in biological or healthcare science, biological, healthcare or scientific discipline
Why GSK?
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:
- 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
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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