Site Name:
Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka
Posted Date:
Aug 1 2025
Regulatory Specialist, Submission Coordination
works closely with global submission teams, Local Operating Company regulatory contacts) to deliver end-to-end submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.This role offers an excellent opportunity
to develop your expertise
in Regulatory Affairs while collaborating with cross-functional teams and gaining exposure to global submission processes.
Basic Qualification -
- Responsible to deliver marketing applications and lifecycle maintenance submissions including activities such as product renewals, site submissions, variations within agreed timelines, in compliance with Regulatory Authority regulations and guidelines, GSK SOPs, and working practices, and in collaboration with relevant submission teams as needed.
- Coordinate MSR for various types of submission, independently and confidently executing agreed dossier strategy. Assist in scenario planning when multiple regulatory strategies are considered.
- Identify and escalate risks associated with submission delivery that have business impact.
- Understand and apply regulations, guidelines, procedures, and policies relating to the registration and manufacturing of pharmaceutical products to expedite submission delivery. delivery.
- Participating in process improvement initiatives, as required
- Participate as needed in submission teams to support product regulatory authority submissions or maintenance activities for approved products, including product renewals, site registrations/renewals/variations, and periodic benefit risk evaluation report (PBRER) submissions.
- Mentoring/training of other team members as required.
Why you?
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Degree in a biological, healthcare or scientific discipline or Extensive experience in the Regulatory Affairs area.
- Understanding of the pharmaceutical industry, R&D processes and objectives.
- Ability to interpret regulations
- Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
- Ability to think flexibly in order to meet shifting priorities and timelines.
- Good written and verbal communication skills and ability to present information in a clear and concise manner.
- Good organizational skills, attention to detail and commitment to deliver high quality output in a timely manner.
- Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
- Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc.
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.
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