Are you a Regulatory Affairs and Business Development Manager who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, Regulatory Affairs and Business Development Manager role is the one for you to explore.As a Regulatory Affairs and Business Development Manager, you will be Managing CMC and labeling variations team. Managing Veeva and Regulatory database team. Avoid and help solving supply issues related to variations. Evaluation, preparation, coordination &submission of regulatory documents in compliance with local regulations, Ensure regulatory compliance, timely submissions & secure regulatory approval in GNE markets.Managing all the internal processes between GNE-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.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Key Responsibilities:Regulatory:

• 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. And 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. Providing guidance on the approval processes to marketing colleagues within the region and providing regulatory input for launch planning. And Providing regulatory and legislation insight to guide the development of business strategies.
• 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 including: Manufacturing site registration and license maintenance. and Responsible for coordinating the MSRs to ensure right first time dossiers are provided.
• Establish effective communication and continuous follow-up with the external agencies & distributors to ensure timely submissions and approvals of all companys applications including HAQs management. And circulate approval announcements.
• Providing artwork creation support to all GNE Markets, including follow up on translations if applicable, 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.
• 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.
• Ensure alignment of regulatory objectives with GNE strategies, regional / global regulatory objectives and commercial plans.
• 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. Help in shaping regulatory environments by shaping regulations.
• 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 and Ensure compliance with company's SOPs and working practices for Good Regulatory Practice.
• Show leadership skills as you are fully accountable and responsible to manage a team and ensure developing the team members.
• Responsible for departmental quality and risk management including but not limited to:

• Update of departmental risk register and follow up on risk related communications.
• Conduct departmental self-inspection monitoring activities. And POC for departmental Audits.
• Develops and maintain departmental SOPs matrix, prompt gap analysis and SOP review as required.
• Maintenance of departmental training check list.
• Conducts assessments of third-party distributor regulatory function, coordinate and develop of remedial plans and follow up on their completion.

Business Development:Special projects (e.g Localization & Manufacturing / Vaccines /Oncology Communications & Networking relation):

• Liaising with CMOs and Health Authorities for project sequencing and submission planning
• Coordination with Supply and Sites to manage the needed importation to avoid supply interruption.
• Coordination will all stakeholders to manage timelines deliverables in terms of approvals and managing risks of re-pricing and supply stock built.
• supporting the business by sharing contributions related to stakeholder mapping.
• Ensuring regulatory processes/ approvals help achieving commercial objectives.

MMW and extended role supporting supply:

• Securing all special import permits needed to manage smooth supply
• Managing all needed coordination and communication with Health Authorities in the fee zone managing regular importation and export to other Gulf Countries.
• Liaise with supply team to facilitate all needed documents and permits for exportation.
• Supporting the RDC for vaccines (Regional Distribution Centre) in the Gulf proposal and implementation if selected.

Why you?Job Qualifications:We are looking for professionals with these required skills to achieve our goals:

• UAE National
• Bachelor of Pharmacy.
• At least 5 years experience in the Gulf - preferably with Regulatory Affairs or working in Government Sector
• Previous experience of managing projects is desirable.
• Previous experience of managing or leading a team is desirable.

Other related skills:

• Excellent knowledge Microsoft office packages, word processing, access and outlook applications.
• High Performance Behaviors:
• 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.

Closing Date:25/03/2024Why 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, its 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. Were 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

GlaxoSmithKline