EMAN KAILANI
Dubai,UAE
Summary
A seasoned regulatory professional with extensive expertise in Innovative Drugs, OTC, food supplements, herbals, and medical devices. Demonstrates a strong understanding of Middle East regulations for new submissions and maintenance activities, coupled with well-established experience in CTD, eCTD, and NEES files. Proven ability to foster strong relationships with Middle East Health Authorities and manage regulatory strategy and market access. Adept at pricing, health authority engagement, product lifecycle management, team leadership and talent development. Skilled in compliance and risk management, cross-functional collaboration, conflict resolution, leading changes, research and development. Possesses audit and inspection readiness along with knowledge of ICH guidelines. Exceptional communication skills complemented by attention to detail, presentation skills, good negotiation skills and product labelling oversight.
Overview
21
21
years of professional experience
1
1
Certification
Work history
Senior Regulatory Affairs Manager- Middle East
Haleon Inc.
, UAE
2022.07 - Current
- Provided advisory support during audits; resulted in fewer discrepancies noted by auditors.
- Developed standard operating procedures to streamline routine tasks and improve productivity.
- Optimised product development timelines by integrating regulatory considerations early on.
- Maintained up-to-date knowledge on relevant legislation, ensuring business operations remained compliant at all times.
- Led negotiations with authorities, achieving favourable outcomes for the company.
- Liaised with health authorities for successful product registrations.
- Achieved regulatory compliance by meticulously reviewing product labels and packaging.
- Trained new employees effectively reducing their learning curve and increasing productivity sooner than usual.
- Collaborated with international teams for effective management of global projects.
- Streamlined internal processes to enhance efficiency in regulatory affairs.
- Delivered leadership on regulatory process and strategy for £2.5+ innovation projects, consistently meeting quality, time and budget targets.
Senior Regulatory Affairs Manager – Nutrition & Skin Care, GNE
GlaxoSmithKline Consumer Healthcare
2020.07 - 2022.07
- Responsible to create regulatory strategies and plan aggressive registration plans for new products, major changes and life cycle management.
- Maintain product licenses in compliance with local regulations
- Lead and manage the various regulatory teams at the distributors in each of the markets to ensure optimized and compliant Registration procedures.
- Ensure that strategic regulatory input into global regulatory strategies is provided, thus providing optimal support
- Develop strong partnerships with Country Managers, Medical, Marketing and Supply Chain and pro-actively ensuring Regulatory input is provided to optimize the project management and to expedite the registration of new products.
- Develop and execute strategies to improve (or maintain) the legislative, regulatory and recommendation environment to better achieve business goals of GSK
- Establish and maintain strong relationships and represent GSK with key members of federal & local governmental, regulatory bodies and Regulatory Key Opinion Leaders.
- Ensures Regulatory compliance of Product Artwork and all promotional materials addressed to his/her market to local legislation and code
- Ensure that the business is aware of possible legislation changes that could impact GSK and advise senior management on appropriate course of action
- Be the Claims Validation Manager of the company in his/her region of responsibility and sign off all consumer claims.
- Responsible for the development, leadership and performance management of the regulatory teams at our various distributors to achieve company objectives. Develop and enhance the capabilities and capacities of the distributor teams through clear direction, coaching and providing scientific support.
- Active participation in local trade organization where applicable and proactively lead the development of trade associations where not existing.
- Effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations/codes and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders.
- Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies.
- Create the regulatory strategy and aggressive registration plans to assure speed registrations.
- Acquire high Lobbying skills with local authorities to support the business.
- Active member of industrial regulatory associations.
- Frequently visiting local authorities in countries of scope
- Establish close relationships with relevant government bodies, KOLs, and relevant associations to support company strategy
- Ensure proper archiving for all related document.
- Report any risks to their line managers.
- Be part of PIRC management.
- Be part of recall incidents.
- Review and approve technical and quality agreements.
- Lead regulatory Audits and inspections as required.
Senior Regulatory Affairs Manager – Middle East
Pfizer Consumer Healthcare
, UAE
2019.11 - 2020.07
- Driving the growth and expanding the PCH portfolio in the Middle East (GCC, KSA & LEVANT) by identifying new products for registration, along with assessment of requirements, risks and mitigations.
- Developing submission and registration plans /strategies for new products, license transfers, site registrations, product renewals, major and minor variations for Consumer Healthcare products in above regions.
- Leads submission team for complex regulatory applications, ensuring they comply with internal standards and external Health Authorities requirements.
- Provides expertise, guidance, and awareness to the product teams and global functions in support of dynamic Health Authority Regulatory requirements.
- Promotes compliance with Regulatory guidance and rules by contributing to the accurate and timely interpretations, assessment of impact across effective communication.
- Ensure promotional materials compliance with internal policies and local Health Authority regulations.
Regulatory Affairs Lead- Middle East, Turkey & SEE
Pfizer Consumer Healthcare
2019.06 - 2019.11
- Driving the growth and expanding the PCH portfolio in the Middle East (GCC, KSA & LEVANT), Turkey & SEE (Estonia, Latvia, Lithuania, Bulgaria, Slovenia, Croatia, Serbia, Bosnia & Macedonia) by identifying new products for registration, along with assessment of requirements, risks and mitigations. Enabling access to new geographies (including Iraq and Iran) by assessing the regulatory environment, trends & requirements for PCH portfolio introduction. Directly managing a team of Regulatory Affairs Officer and Labeling Coordinator.
- Developing submission and registration plans for new products, license transfers, site registrations, product renewals, major and minor variations for Consumer Healthcare products in Gulf, Levant, and KSA.
- Assisting commercial colleagues in establishing launch timelines and supply management through communicating submission approval timelines and risk management.
- Setting and managing regulatory budget through periodic review of current and future expenditure plans.
- Supporting the creation and/or execution of local SOP for labeling, promotional materials, sampling and medical response in line with regional guidelines and regulations.
- Reviewing and approving labeling and artworks in addition to promotional materials for submission to Regulatory Authorities.
- Ensure that all marketed products in the country are in compliance that meet local and corporate regulatory requirements, i.e. labeling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that were registered with the MOH.
- Build a pricing strategy for new innovations and during the maintenance of registered products.
Regulatory Affairs Manager- Middle East
Pfizer Consumer Healthcare
2015.09 - 2019.05
- Registration planning
- Dossier submission and product Approval
- Regulatory Compliance:
- Regulatory Influence
Senior Regulatory Affairs Officer- Middle East
Pfizer Consumer Healthcare
2013.04 - 2015.08
- Registration planning
- Dossier submission and product Approval
- Regulatory Compliance
- Collaborated cross-functionally with various departments to ensure alignment in regulatory affairs strategy.
- Regulatory Influence
Regulatory Affairs Officer- Middle East
Pfizer Consumer Healthcare
2011.01 - 2013.04
- Registration planning
- Dossier submission and product Approval
- Regulatory Compliance:
- Regulatory Influence
Regulatory Affairs Associate- Middle East
Pfizer Consumer Healthcare
, UAE
2010.09 - 2010.12
- CMC (Chemistry Manufacturing & Controls) Change Control Management
- Performing local regulatory assessments for CMC change controls following manufacturing plant
process and forms - Notifying Authority of CMC updates ready for submission.
- Maintaining Regulatory Databases
- Perform local deployment activities required for Regulatory databases development, which including
data load of all registration details of currently registered products in MENA and then verifying this
information. - Keeping regulatory records on local databases.
R&D Associate + Professor Assistant
University of Science & Technology (Pharmacy Faculty) – Jordan
, Jordan
2005.03 - 2006.08
- Development of polymeric controlled-release membranes, contributing to formulation optimization and lab-scale trials.
- Performed material testing and characterization of polymers, assessing permeability, stability, and performance under varied conditions.
- Coaching for Industrial Pharmacy Laboratory Courses.
- Developed innovative solutions using scientific methods and principles.
Education
B.SC Degree - Pharmacy
Jordan University of Science & Technology
JordanSkills
- Regulatory (OTC, Food Supplement, Herbals, Medical Devices)
- Broad experience in Middle East regulations for new submissions and maintenance activities for Drugs, Food Supplements and Medical Devices
- Very well-established experience in CTD, eCTD and NEES files
- Strong relationships with Middle East Health Authorities
- Management
- Team management
- Regulatory Strategy & Market Access
- Pricing
- Health Authority Engagement
- Product Lifecycle Management
- Team Leadership & Talent Development
- Compliance & Risk Management
- Cross-Functional Collaboration
- Management of OTC advertisement & campaigns approvals
- Conflict resolution
- Leading changes
- Research and Development
- Self-Awareness
- Audit and inspection readiness
- Medical device regulations
- Knowledge of ich guidelines
- Leadership capabilities
- Product labelling oversight
- Attention to details
- Communication skills
- Presentation skills
- Good negotiation skills
PERSONAL PROFILE
Arabic — mother tongue
English—fluent
German— fair
REFERENCES
Available upon request.
Accomplishments
- Managed for the first time in Pfizer Consumer HealthCare Middle East history to obtain UAE MoH approval for Centrum Campaign identified as the 1st ever integrated 360 campaigns.
- Achieved the switch of Advil 200 mg tab and Liquigels dispensing mode from Pharmacy Only Medicine (POM) into OTC-General Sale in UAE.
- Achieved the switch of Advil 200mg tan and Liquigels from controlled- price products into freely-priced products.
- Achieved the approval of Centrum portfolio dispensing in General Sale Outlets in UAE.
- Managed to obtain registrations of Food Supplements in different Middle East markets stable under zone II stability.
- Led MENAP (trade association) taskforce assigned to amend the classification regulations in Jordan, to successfully achieve the JFDA alignment with the SFDA and global classification regulations.
- Increased profitability for Centrums in Middle East by proposing a COGs decrease plan and achieving Health Authorities approval to; included leaflet removal, deletion of non-mandatory warnings and extending the shelf-life.
- Reclassified Stresstabs with Zinc from a controlled-price drug into a freely-priced GSL in UAE based on a presented case to the MOH
- Successfully registered Thermacare Heat Wraps medical device in Saudi Arabia in 2 months to meet launch plan
- Managed to register the first company experience of dietary supplements classified as drugs in Saudi Arabia (in 2013) and Jordan (in 2018) required the submission of full CTD sections.
- Accelerated Centrum innovations in Middle East by developing a guidance document about Middle East formulation requirements shared with global R&D.
- Expanded Centrum and Advil portfolios in Middle East region by waiving many requirements linked to established registrations from same molecules.
- Accelerated innovations in Middle East by waiving site inspection requests in key markets and following the achievements of MoH acceptance for product submissions before the site approvals.
- Advil Night registration in Middle East region within expected timelines as a first experience in eCTD format in the region.
- Maintained Commercial access to the Iraqi market despite the consequent changes in the regulations and in the assigned local distributor with the achievement of first Pfizer Food Supplement and pain killer registrations with desired prices.
- Established Local Work Instructions / Job Aids for the Middle East Regulatory department in line with global SOPs.
- Led the Due Diligence project for the change in the Legal Entity from Wyeth to Pfizer following the acquisition and within determined timelines.
- Identified as a Top Performer in the Middle East regulatory consumer team during 2014
- Awarded with PFIZER OWN IT AWARD for 2015 &2017
- Selected amongst the team of finalist for the 2015 Commercial Excellence Awards based on the role in the registration/launch support of Thermacare in different Middle East markets.
TRAININGS
- CTD (by al Mesned)
- ECTD (by al Mesned)
- MERN Medical Devices Regulations (by Management Forum)
- Unconscious Bias
- Comprehensive Professional Manager (Atton Institute)
- Category Management Program (By Nielson)
- Finance for Non-Finance (by CCM Consultancy)
Certification
Core Regulatory & Pharma Training
Regulatory Affairs in Pharmaceutical Industry (Lifecycle Management)
ICH Guidelines (ICH Q7–Q12 Overview)
CTD / eCTD Dossier Preparation & Submission
FDA Regulatory Requirements (21 CFR Compliance)
EMA Regulatory Framework & EU GMP
🧪 Quality & Compliance
Good Manufacturing Practice (GMP / GxP Training)
Quality Management Systems (QMS) in Pharma
CAPA & Deviation Management Systems
💼 Business & Leadership
Finance for Non-Financial Managers
Project Management / Stakeholder Management in Pharma Core Regulatory & Pharma Training
Timeline
Senior Regulatory Affairs Manager- Middle East
Haleon Inc.
2022.07 - Current
Senior Regulatory Affairs Manager – Nutrition & Skin Care, GNE
GlaxoSmithKline Consumer Healthcare
2020.07 - 2022.07
Senior Regulatory Affairs Manager – Middle East
Pfizer Consumer Healthcare
2019.11 - 2020.07
Regulatory Affairs Lead- Middle East, Turkey & SEE
Pfizer Consumer Healthcare
2019.06 - 2019.11
Regulatory Affairs Manager- Middle East
Pfizer Consumer Healthcare
2015.09 - 2019.05
Senior Regulatory Affairs Officer- Middle East
Pfizer Consumer Healthcare
2013.04 - 2015.08
Regulatory Affairs Officer- Middle East
Pfizer Consumer Healthcare
2011.01 - 2013.04
Regulatory Affairs Associate- Middle East
Pfizer Consumer Healthcare
2010.09 - 2010.12
R&D Associate + Professor Assistant
University of Science & Technology (Pharmacy Faculty) – Jordan
2005.03 - 2006.08
B.SC Degree - Pharmacy
Jordan University of Science & Technology