Regulatory Affairs Specialist

Site Name: Egypt - Cairo
Posted Date: Oct ‎17 ‎2023

Job Purpose:
* Responsible for timely delivery of regulatory activities of assigned Rx and/or Vx projects across dosage forms with minimal input from line manager.
* Supports Global Regulatory by producing appropriate components for global regulatory dossiers with minimal input from line manager.
* Has training/mentoring responsibilities for new staff on established departmental processes.
Key Responsibilities:
* With minimal input from manager, executes agreed dossier strategy.
* With minimal input from manager, manages multiple Rx and/or Vx project assignments simultaneously; dossiers will range in complexity.
* With minimal input from manager, completes data assessment to ensure dossier is fit for purpose.
* With minimal input from manager, identifies risks associated with submission data and information packages.
* Communicates with line manager to identify issues that have business impact.
* May act as reviewer/approver for dossiers prepared by peers and may identify improvement opportunities for Regulatory processes, policies and systems.
* Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications. Serves as mentor/trainer for new staff.
* Understands internal/external Regulatory environment.
* Actively builds an organizational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
* Communicates across GSK, with minimal input from manager regarding project and policy issues ensuring optimum position for GSK.
Key Requirements:
* Bachelor's Degree in Pharmaceutical Sciences
* ‎1-‎3 years experience in a similar role
Closing Date: ‎25/‎10/‎2023
Why Us?
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 organization where people can thrive. Getting
ahead means preventing disease as well as treating it, and we aim to
positively impact the health of ‎2.5 billion people by the end of ‎2030.
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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