Regulatory Officer

Site Name: Saudi Arabia - Jeddah
Posted Date: Dec ‎12 ‎2022

Job Purpose:
Ensure site regulatory compliance with all Saudi Drug Authorities (SFDA)
requirements. Prepare registration dossiers for local and export markets and
QC stability. Ensure new product specifications are complying with registered
details, prepare variations packages and suppliers files. Submission of
renewal & registration packages for export in addition to a timely response
to regulatory authority's queries. Ensure the alignment of registered
information with current site practices. Handle regulatory documents required
for tenders.
Your Key Responsibilities
This role will provide YOU the opportunity to lead key activities to
progress YOUR career, these responsibilities include some of the following …
Key Responsibilities
* Prepare registration dossiers for local and export markets and maintain good archiving system.
* Responsible for preparing Quality documents required for renewal of the products.
* Ensure product specifications are complying with registered specs.
* Prepare and Submit site registration application/ form submission, renewal & registration packages for export (dossiers, POA, declarations, samples, CPP, GMP, SFDA applications. …etc)
* Prepare QC stability studies files and AMVs scanning required to be submitted to regulatory affairs team.
* Prepare registration dossiers for addition of suppliers to MA.
* Ensure the alignment of registered information with actual processes and current practices.
* Fulfil regulatory authorities requirements (Post approvals, renewal requirements, new Guidelines….etc)
* Review and approve COAs of FP to comply with registered details for local and export markets that will be submitted to regulatory authorities.
* Conduct L1 inspections on regulatory department according to planned schedule, make the use of GPS tools for effective performance and on-going improvement in ways of working. Ensure that EHS policies and procedures are implemented during work.
* Direct interaction - handling - communication with MOH/ SFDA (Saudi food drug authorities).
* Ensure site compliance with SFDA requirements/guidelines.
* Responsible for site variations submissions and updating registration data to local SFDA following CCR's and regulatory changes.
* Responsible for SFDA site documents management and control (Keep all correspondences or documents sent or received through the company, NODCAR, or SFDA and retain them according to GSK retention policy schedules.)
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our
goals:
* Bachelor degree of Science or Pharmaceutical Science
* Minimum ‎3 years experience in a similar position, preferably in a multi-national pharmaceutical company.
* Breadth of knowledge required is moderate with knowledge of SFDA guidelines, production processes and laboratory analysis required.
* Proficient level of English language. [Written & Spoken]
* Good documentation ability.
* Good in Computer skills (Microsoft office )
Why GSK?
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 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 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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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