Regulatory Affairs Specialist

Site Name:* Egypt - Cairo
Posted Date: Jan ‎17 ‎2023

Job Purpose:
* Evaluation, preparation, coordination &submission of regulatory documents in compliance with local regulations
* Ensure regulatory compliance, timely submissions & secure regulatory approval in Gulf markets.
* Managing all the internal processes between Gulf-RA and the central team.
* Enable the company to achieve its objectives by obtaining marketing authorization approvals/ license maintenance on time.
* Strategic planning for life cycle maintenance.
* Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment.
* Communication and maintenance of product registration to ensure alignment with all stakeholders. :
Core Responsibilities:
* Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment.
* Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements.
* Manufacturing site registration and license maintenance.
* Responsible for coordinating the MSRs to ensure right first time dossiers are provided.
* Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals.
* Establish effective communication and continuous follow-up with the external agencies & distributors to ensure timely submissions and approvals of all company's applications.
* Monitoring of emerging legislation changes affecting business and communication to relevant internal customers.
* Implementation of existing legislative in working practices.
* Providing guidance on the approval processes to marketing colleagues within the region and providing regulatory input for launch planning.
* Providing regulatory and legislation insight to guide the development of business strategies.
* Providing artwork creation support to all Gulf Markets, through using the supportive documents & complying with the company SOPs & local guidelines in a timely manner.
* Follow up to ensure that the locally manufactured/packaged artwork (if applicable) is compliant with the latest label updates.
* Authorize approval of technical changes in artwork/ GEXP updates.
* Responsible for follow up with translation providers directly or indirectly for timely provision of Arabic text to be incorporated to Local leaflets.
* Announcement of regulatory approvals to all concerned stakeholders.
* Maintenance of all lifecycle activities/ Product license details in Veeva by accurately updating all submissions and approval within the preset global timelines -accountable for overall accuracy and compliance.
* Renewal event creation for active licenses for the respective Gulf Markets
* Review of regulatory information enclosed in technical terms of supply prepared by QA.
* Ensure alignment of regulatory objectives with Gulf strategies, regional / global regulatory objectives and commercial plans.
* Accountable for solving all supply issues related to regulatory activities.
* To work with GRA and local teams thus ensuring local needs are considered in Global/Regional regulatory strategies which support the strategic planning process, local inputs to dossier development.
* To provide regulatory intelligence e.g. liaising with local market-based colleagues, professional staff at regulatory agencies etc to facilitate the review and approval of regulatory submissions.
* Ensure compliance with company's SOPs and working practices for Good Regulatory Practice.
* Update and maintenance of local and global databases supporting compliance and centralization of data within Regulatory Affairs .
* Management of documentation archiving and record keeping according to SOP and local legislation.
* Can support and assist in minor projects e.g. Veeva / PLCR
* Can be accountable for minor projects on behalf of Gulf team
* Can be Accountable for above area projects or on large scale projects on behalf of Gulf team
Scope:
Market authorization approvals and lifecycle maintenance activities in Gulf
Markets (UAE, Kuwait, Qatar, Bahrain & Oman).
Accountability:
* Timely submissions and approvals of all regulatory dossiers, to ensure supply compliance with the registration details.
* Building professional relationships with all stakeholders internally and externally
* Accountable for ensuring implementation of in scope GSK Global and Local SOPs, policies and procedures in all activities and tasks.
* Accountable for maintenance of all lifecycle activities in the relevant regulatory systems
* Identifying all potential risks and update to all relevant stakeholders.
* Complying to local authority guidelines
* Accountable for ensuring labelling compliance to the latest labelling information.
Complexity:
* Working with different stakeholders including logistics team, supply team, marketing team, central regulatory affairs team, GMS and health authorities.
* Numerous and frequent variation changes for our portfolio.
* Unclear guidance from our local health Authority.
* Complexity of online tracking systems.
* Rapidly changing regulations
* Interactions with multiple stakeholders
* Various queries from GSK distributors
* Multiple MOH's each with their own requirements and guidelines & Applications.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our
goals:
* Bachelors of pharmacy.
* English / Arabic
* Minimum ‎3 year experience in regulatory affairs.
* Experience with Gulf and Near east Health Authorities
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Experience in pack and artwork management
* Experience with Veeva systems
High Performance Behaviours:
* Highly enthusiastic, self motivated, committed and dedicated personality.
* Positive attitude towards creating business solutions.
* Good communication skills (both verbal and in writing).
* Ability to work independently as well as in teamwork.
* Capacity to establish positive interpersonal relations and interact effectively with cross functional teams
* Capacity to work accurately under pressure to meet project timelines.
* High attention to details.
* Ability to work in a fast- paced, technically skilled, team setting.
Why GSK?
Our values and expectations * are at the heart of everything we do and form
an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with
Courage, Accountability, Development, and Teamwork. As GSK focuses on our
values and expectations and a culture of innovation, performance, and trust,
the successful candidate will demonstrate the following capabilities:
* Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
* Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
* Continuously looking for opportunities to learn, build skills and share learning.
* Sustaining energy and well-being
* Building strong relationships and collaboration, honest and open conversations.
* Budgeting and cost-consciousness

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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