Summary
Overview
Work History
Education
Skills
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Personal Information
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Timeline
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Shaimaa Elmeligy

Shaimaa Elmeligy

Dubai ,Dubai

Summary

Seasoned regulatory affairs professional with over 20 years of experience in the pharmaceutical industry, including 14 years in regulatory affairs. Extensive expertise in regulatory strategy, pharmacovigilance, and quality leadership, with a strong background in technical transfer projects, product acquisitions and divestments, and lifecycle management. Skilled in regulatory submissions and post-marketing compliance. Proven ability to lead cross-functional teams, collaborate with health authorities, and drive regulatory excellence to support business growth and patient safety.

Knowledgeable Pharmaceutical Affairs director with proven history of leading high-performing teams and executing strategic initiatives that drive organizational growth. Successfully directed cross-functional projects that resulted in significant process improvements and operational efficiencies. Demonstrated leadership and communication skills in fostering collaborative environments and delivering impactful results.

Overview

21
21
years of professional experience

Work History

Pharmaceutical Affairs Director MENAT Region and Scientific Office Responsible Pharmacist

Aspen Pharma group
10.2017 - Current
  • Provide strategic leadership and direction to the department activities in the Middle East region
  • Manage pharmaceutical affairs team, including hiring, training, and performance management
  • Manage more than 5 global acquisition for multiple MN companies like GSK/ AstraZeneca/ MSD and Novartis which strengths the presence of Aspen in MENA region
  • registered successfully 6 new molecules in Europe through Aspen MAH affiliate in Malta and registered the same products across MENA region which participate in annual 10% of the company revenue in past 5 years.
  • Stay abreast of changes in regulatory requirements and assess the impact on current and future projects within the department
  • Develop and manage budgets for pharmaceutical affairs department in MENAT, including submission fees, consulting fees, Systems, and regulatory compliance expenses
  • Monitor spending against budgetary targets and implement cost-saving initiatives where appropriate
  • Ensure that business unit KPIs for the region is shared with the team and it is clear to team members to achieve the financial objectives
  • Conduct regulatory and pharmacovigilance due diligence for any new business development opportunity, acquisition and mergers are completed as per the agreed plan and assess the impact of the proposed business deal on regulatory compliance, including requirements related to product registration, marketing authorization, distribution, and pharmacovigilance
  • Ensure that regional/local Regulatory activities are implemented as per agreed plans and appoint project team members associated with the implementation of new deals and projects
  • Develop and implement regulatory strategies to ensure compliance with local and international regulations and act as the main point of contact for regulatory agencies and Aspen affiliates across MENAT region
  • Support commercial, business development and pricing teams during assessment of new potential molecule pricing estimation, product acquisitions and marketing authorization transfer
  • Ensure that the pricing team are aware of any change in pricing regulations across region and support impact assessment on other markets across the region against annual forecast and budget impact assessment
  • Provide all necessary regulatory guidance and support for the introduction of new indication, line extension and change of product mode of dispensing from the concept to commercialization
  • Assess regulatory requirements for new markets and develop strategies for market entry
  • Collaborate with legal and business development teams to ensure regulatory compliance in all transactions
  • Manage waivers requests to ensure supply smoothness and limit out of stock situations
  • Monitor commitments to health authorities on behalf of the marketing authorization holder and ensure that all commitments are closed in a timely manner
  • Ensure Sunset-clause monitoring and management for the EU MAs
  • Escalate any identified parallel trade, suspected counterfeit and reporting to top management and legal team
  • Oversee the regulatory aspects of technical transfer projects in MENA region and act as main point of contact between the sending site and receiving site within the region
  • Ensure compliance with regulatory requirements and quality standards during the transfer of manufacturing processes, analytical methods, and product specifications
  • Coordinate with manufacturing, quality assurance, and in market regulatory contact to facilitate smooth technical transfers
  • Coordinate regulatory audits and inspections conducted by health authorities or regulatory agencies
  • Ensure compliance with regional pharmacovigilance regulations and guidelines, including those set forth by health authorities in the Middle East (e.g., Saudi FDA, UAE Ministry of Health)
  • Monitor regulatory developments and changes in pharmacovigilance requirements across the region and implement necessary updates to policies and procedures
  • Ensure timely and accurate reporting of adverse events to regulatory authorities and other stakeholders
  • Build and maintain relationships with regulatory authorities and external stakeholders and support medical and marketing teams in external communication with key opinion leaders if needed
  • Represent the company in pharmacovigilance forums, industry associations, and regulatory meetings
  • Provide pharmacovigilance expertise and guidance to internal and external stakeholders on safety-related matters
  • Collaborate with other functional areas within the company, including regulatory affairs, medical affairs, marketing, and quality assurance, to ensure alignment of pharmacovigilance activities with overall business objectives
  • Holds MOH license and act as pharmacist in charge of the scientific office and act as a back-up pharmacist for GDP pharmacist
  • Respond to authorities' inquiries and governmental representations in UAE
  • And act on behalf of the MAH
  • Ensure that the scientific office and freezone warehouse are operating in line with local legislation
  • Coordinate with global compliance team in reviewing the quarter and annual legislative compliance review and notification of any change in regulatory landscape in UAE to head of compliance and CEO

Regional Regulatory affairs manager, Pharmacovigilance manager and Quality officer

Bluefish Pharmaceuticals AB-Sweden
09.2014 - 07.2017
  • Acting as a point of contact on behalf of Bluefish Pharmaceuticals with regards to pharmacovigilance, quality assurance and regulatory activities towards patients, healthcare professionals and Competent Authorities in the territory
  • Actively contributes to the development and implementation of regulatory strategy for assigned projects
  • Prepare, coordinate, manage or maintain regulatory submissions in accordance with applicable regulations
  • Translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival)
  • Act as liaison between Regulatory Affairs and other functional areas, represent regulatory affairs in cross functional team meetings
  • Daily follow up and communicate effectively with regulatory authorities to obtain timely product approvals
  • Keeping up to date with changes in regulatory legislation and guidelines by attending meetings with MOH
  • Preparing variations files, pricing documents and renewals files to strict deadlines
  • Provide central regulatory team with updated registration requirements for new project/variations
  • Follow up on artwork compliance per regulation, to avoid delay or rejection of any shipment due to artwork
  • Develop regulatory strategies and implement plans for the preparation and submission of new products
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
  • Monitoring local PV legislation, implementing changes, and informing Bluefish of any relevant changes
  • Being available to support to the EU QPPV during working hours and support EU QPPV in any local safety matter
  • Alerting the QPPV about any issue or potential issue related to the safety profile of products under Bluefish responsibilities
  • Informing the QPPV of any requests for PV-related information from CAs and of any ADRs concerning safety data provided to the CAs
  • Sending all source data related to safety information of Bluefish products immediately to Bluefish Pharmaceuticals for final archiving
  • Collecting, reporting and follow-up of the safety information from all sources, including local CAs along with source data
  • Maintain a tracking list of local ICSRs and non-valid cases in the territory
  • Ensuring that ADRs received out of normal office hours are handled to meet internal and regulatory reporting timelines
  • Ensuring that pharmacovigilance activities are conducted in compliance with Bluefish internal procedures and local, EU- and worldwide- PV legislation
  • Ensuring compliance with local and EU legislation relating to patient and reporter confidentiality (personal data act)
  • Ensuring quality control of the English translation and accuracy of data against the source data
  • Submitting monthly reconciliation reports to the Bluefish PV department
  • Responsible for annual PV training for Bluefish partner in ME
  • Qualified licensed pharmacist responsible for regional hub GSP activity
  • Working with the region's commercial affiliates to provide support and guidance to local territory
  • Assure products distributed in region conform and applicable to regulatory standards and Quality standards, to assure readily available supply of compliant, authentic, safe, and efficacious products Providing Quality Systems leadership and strategic direction as well as technical support to at commercial affiliates in the region
  • Assessment Logistics Service Providers, Third Party Warehouse, and regional distributor's qualifications and compliance with company QMS
  • Handling the quality agreement on a regional level with company's distributors
  • Handling products complaints and act as local recall administrator in case of recall
  • Act as the point of contact for the national competent authority regarding quality matters

Regional Regulatory Affairs Manager

Al-Hikma FZCO
01.2014 - 09.2014
  • Responsible for the registration and re-registration of the company product at UAE Ministry of health and Dubai Municipality
  • Supporting the logistics team to ensure safe receipt of the shipment to UAE and from UAE to other markets
  • Responsible for preparing data analysis, market survey and evaluation procedure
  • Responsible for arranging the analysis requirements, order of reagent and reference standard to fulfill products analysis requirements in different markets
  • Responsible for Iraq registration of products from different companies like, Tabuk pharmaceutical KSA, Medpharma UAE, Himalaya, Octapharm and 3M and
  • Registration of cosmeceuticals brands in Egypt, Sudan, Iraq, Iran, Libya and KSA
  • Registration of herbal and food supplements in Syria, Jordan, Iraq, Yemen, Bahrain and KSA
  • Handling the packing and product artwork as per the market needs
  • Handling FMCG product registration in different countries across MENA
  • Purchasing the laboratory requirements like reference standard, reagent and impurities for different markets
  • Support food supplements and herbal manufacturers to fulfill the documentation requested by quality control laboratories for successful analysis of the products

Regulatory affair manager

Muscat Pharmaceutical Trading
01.2012 - 01.2014
  • Responsible for registration and re-registration of all company products
  • MAH and manufacturing sites registration
  • Checking the availability of the required documents and the proper attestation
  • Checking Minor Variation files documentation as per MOH guidance
  • Doing the follow up with the principal companies to assure the smoothness of registration process dealing with all the types of files for GSL, Conventional, Herbal, Medical devices, Homeopathic medicines and company registration files
  • Responsible for FMCG products registration at Dubai Municipality
  • Muscat Pharmaceutical Trading (MPT) was one of the companies awarded Best Company in the sector of Health Care and Health Supplements by Dubai Government and Dubai Municipality for the period of 2011 and 2012
  • Responsible for advertisement approval from MOH and Dubai municipality
  • Supporting the logistics team by playing a key role in clearing the consignments
  • Representing the companies at MOH and all workshops held under the sponsorship of MOH to keep track of any update in regulations
  • Preparing the Arabic/English artwork for inserts and outer pack
  • Good command with different software to handle the labelling and artwork as per local requirements
  • Checking QCL files documents and confirming documents availability before submission to MOH lab
  • Preparation of presentation for principal companies and doing monthly update about the registration status to mangers and principles as well
  • Registration renewal of GCC centrally registered products
  • I did the registration of many products and achieved a great record for the organization

Unit manager

ASTER Retail Pharmacy Chain
02.2006 - 12.2011
  • Assemble a great team and schedule their work so the pharmacy is always functioning at peak performance
  • Supervise the fulfillment of prescriptions by pharmacy technicians
  • Communicate with insurance company's policy, procedure, exclusion, and payment
  • Review all the daily insurance claims which exceed 100 daily from more than 20 insurance companies
  • Ensure adequate control and documentation of all controlled substance records and monitor patient medication profiles
  • Work on keeping the pharmacy one of Dubai scheme of excellent service (DSES) member for last three years with an average score of 95%
  • Training of team members to maximize overall team performance
  • Following the daily sales and analyzing the pharmacy sales to achieve the target
  • Follow up with insurance companies for outstanding payment and escalate delay to higher management and finance team

Pharmacist

Life Healthcare Group
06.2004 - 01.2006
  • Ensuring that every customer receives friendly and is getting efficient service
  • I checked all work done by pharmacy technicians prior to dispensing medications
  • Responsible for the purchase of pharmaceutical and nonpharmaceutical products from suppliers and wholesale to achieve the best profit for the pharmacy
  • Following the daily sales and analyzing the pharmacy sales to achieve the target

Education

Executive leadership certificate -

University of Oxford
2021

Intellectual property law Certificate -

University of Pennsylvania
USA

ISO 9001 certified lead auditor -

Non-sterile GMP, GVP vendor and Regulatory vendor lead auditor - across EME region

Sterile manufacturing audit training -

CTD, e-CTD and NEES training certificate -

Certified lead auditor -

Finance for non-finance certification -

Bachelor of pharmacy and pharmaceutical science - Pharmaceutical Sciences

Alexandria University
Egypt
01-2002

Skills

  • Negotiation skills
  • Analytical skills
  • Project management skills
  • Coaching skills
  • Organizational skill
  • Decision-making
  • Strategic planning
  • Relationship building
  • People management
  • Operations management

Languages

English
Arabic

Personal Information

  • Date of Birth: 11/08/80
  • Nationality: Egyptian
  • Marital Status: Married
  • Visa Status: Golden Visa

License

MOH, Active and valid

Timeline

Pharmaceutical Affairs Director MENAT Region and Scientific Office Responsible Pharmacist

Aspen Pharma group
10.2017 - Current

Regional Regulatory affairs manager, Pharmacovigilance manager and Quality officer

Bluefish Pharmaceuticals AB-Sweden
09.2014 - 07.2017

Regional Regulatory Affairs Manager

Al-Hikma FZCO
01.2014 - 09.2014

Regulatory affair manager

Muscat Pharmaceutical Trading
01.2012 - 01.2014

Unit manager

ASTER Retail Pharmacy Chain
02.2006 - 12.2011

Pharmacist

Life Healthcare Group
06.2004 - 01.2006

ISO 9001 certified lead auditor -

Non-sterile GMP, GVP vendor and Regulatory vendor lead auditor - across EME region

Sterile manufacturing audit training -

CTD, e-CTD and NEES training certificate -

Certified lead auditor -

Finance for non-finance certification -

Executive leadership certificate -

University of Oxford

Intellectual property law Certificate -

University of Pennsylvania

Bachelor of pharmacy and pharmaceutical science - Pharmaceutical Sciences

Alexandria University

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Shaimaa Elmeligy