Regulatory Market Requirements Specialist

Site Name: Egypt - Cairo
Posted Date: Feb ‎2 ‎2023

Are you a Regulatory Market Requirements Specialist who is energized by
the challenge of being part of one of the leading pharmaceutical companies
worldwide? If so, this role is the one for you to explore.
As a Regulatory Market Requirements Specialist, you will be responsible
for the efficient management and delivery of Market Specific Requirements.
This role will provide YOU the opportunity to lead key activities to
progress YOUR career, these responsibilities include some of the following:
* Liaise with MSR suppliers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
* Prepare the Market Specific Requirements package for regulatory submissions.
* Ensure appropriate archival of MSR data package.
* Organize dispatch of MSRs.
* Update tracking systems with dispatch dates and event number as defined by process documents.
* Escalates changes through the relevant process.
In addition to above activities, if SC role is being done then following
activities needs to be performed.
* Coordinates the preparation of regulatory submissions (e.g., Renewals, Product Expansion Dossiers for Emerging Markets, Site registrations, Tenders)
* Monitor plans for upcoming submissions .
* Check with relevant groups to understand ongoing regulatory activities that may affect the submission package, agreements, and document strategy.
* Liaise with documentation suppliers to ensure components are delivered in a timely fashion.
* Communicate availability of data package to LOC.
* Maintains knowledge of relevant submission formats and outputs and guidance associated with different formats of regulatory submissions which may differ with each Authority.
* Compliance checks and reformats Regulatory documents when required.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our
goals:
* Bachelor 's degree in biological or healthcare science qualification of Chemistry, pharmacy or other related science or regulatory affairs. Project Management, Communication
* Minimum ‎1-‎3 years of relevant experience.
* Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions.
* Proven ability to work on multiple projects simultaneously.
* Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
* Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
* Excellent English and French, written and verbal communication skills and ability to present information in a clear and concise manner
* Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
* Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
* Ability to build effective working relationships and work in a matrix environment effectively
* Ability to think flexibly to meet constantly shifting priorities and timelines.
Why GSK?
At GSK, we have already delivered unprecedented change over the past four
years, improving R &D, becoming a leader in Consumer Health, strengthening our
leadership, and transforming our commercial execution. Now, we're making the
biggest changes we've made to our business in over ‎20 years. We 're on track
to separate and create two new companies in ‎2022: New GSK with a leading
portfolio of vaccines and specialty medicines as well as R&D based on immune
system and genetics science; and a new world-leading consumer healthcare
company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science,
talent and technology to get ahead of disease together - all with the clear
ambition of delivering human health impact; stronger and more sustainable
shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all
this is through our people and our culture. A culture that is ambitious for
patients - so we deliver what matters better and faster; accountable for
impact - with clear ownership of goals and support to succeed; and where
we do the right thing. So, if you 're ready to improve the lives of
billions, join us at this exciting moment in our journey. Join our challenge
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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