Regulatory Affairs Manager

Site Name: Egypt - Cairo
Posted Date: May ‎30 ‎2022

Are you a Regulatory affairs professional who is energized by the
challenge of being part of one of the leading pharmaceutical companies
worldwide? If so, this Regulatory affairs Manager role is the one for you
to explore.

As Regulatory affairs Manager be responsible for Ensuring the finalization
of new product registration and preparing and submission of renewal files for
all products in due dates according to GSK standard and EDA regulations while
creating and maintaining effective relationships with regulatory authority in
Egypt.
This role will provide YOU the opportunity to lead key activities to
progress YOUR career, these responsibilities include some of the following …
* Ensure Regulatory compliance for all regulatory activities, products registration, labelling update, Artwork and technical changes.
* Maintaining products supply in the market especially after business expansion with the increased products' portfolio giving the company edge over the competitors
* Ensuring ‎100% compliance with RA regulations
* Monitor regulatory environmental changes and rules via effective professional relations with EDA authority, while keeping updated with GSK global legislation and guidelines.
* Liaise and communicate with global regulatory department and MSR team to ensure timely re-registration for all products.
* Ensure timely renewal and variation submission of GSK products per ‎3 years plan
* Support the administrative activities in preparing packages for renewals, variation, stability and analysis files in a timely submission manner under instructions., considering creating all Tasks related to MOH PACs, accompanied with a local PAC tracking sheet for Vx related areas.
* Communicate with MSR and admin. team to overcome any raised issues concerning the renewal documents preparations, timelines as well as responses to MOH questions and NORCB analysis requests.
* Ensure that all dispatched variations and renewal events are submitted to plan and recorded in OPAL.
* Ensure timely submission and approval of labelling files.
* Ensure that all the renewal/ variation files are matching with both GSK standards and EDA requirements
* Update the electronic databases accurately and on a timely manner, besides Creating summary reports related to renewals, variations and labelling for RA manager and ensuring that team site is updated with the latest regulatory data.
* Support marketing and tender business by providing all the requested regulatory data
* Maintain an up-to-date local regulatory archive for Egypt regulations (re-registration/ variations/ labelling procedures / forms / fees & guidelines).
* Managing the artwork of Country specific packs on Harmony and following up with Medical and Marketing for approvals.
* Reviewing all the current artworks & labelling to ensure full compliance & artwork and or leaflets according to the latest approvals and regulatory data every ‎6 months.
* Full awareness of GSK systems OPAL, VeeVa, Explore, E-Core and Harmony
* Support pharmacovigilance colleagues and the global safety with the Regulatory inputs for various Periodic (PSUR, DSUR, PBRER, ACO, RMP), all requirements needed from the global team related to insert updates and marketing status products.
* Ensure LOC readiness for any audit, work on action plan and ensure effective closure.
* Preparation and submission of Pricing files to Pricing Department in EDA and follow up to accelerate the files and approvals in EDA.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our
goals:
* University Bachelor's degree from pharmaceutical, Medicine, or Science.
* ‎6-‎8 years of regulatory experience, Working in registration activities of different products.
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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