Rawan Alkhalaf
Jeddah,Saudi Arabia
Summary
Accomplished regulatory affairs professional with almost 10 years of experience. Managed pharmaceutical registration, variation, and renewal submissions for the KSA and MENA regions. Demonstrates regulatory compliance and legislative interpretation proficiency, ensuring seamless audit and inspection readiness. Skilled in risk management, change control systems, and regulatory strategy development, with a proven ability to oversee product labelling and maintain adherence to global standards. Strong leadership capabilities and experience with pharmaceutical, cosmetics, and food regulations.
Overview
11
11
years of professional experience
4031
4031
years of post-secondary education
Work History
REGULATORY AFFAIRS & SAFETY ASSOCIATE MANAGER PERSONAL CARE
RECKITT
03.2024 - 04.2025
- Support and regulatory inputs for business and launch planning for categories within the scope of responsibility
- Guide the NPD approval processes to marketing colleagues within the Saudi region, and provide regulatory input for GRA for categories within the scope of responsibility.
- Strategic & operational support to the local business unit to deliver major business unit projects in line with established launch plans
- Local strategic inputs to Saudi Region / Plan: Participation in cross-functional meetings and local business unit key decision meetings for categories within the scope of responsibility
- Providing regulatory and legislative insights as required to marketing and sales colleagues
- To work with the local Saudi team, the Middle East team, and the global teams, thus ensuring local needs are considered in regulatory strategy documents that support the strategic planning process and local inputs to dossier development for categories within the scope of responsibility.
- Registration and maintenance of Reckitt products within the JV scope
- Regulatory intelligence - legislation, competition: Monitoring of emerging legislation changes affecting Saudi business and communication to relevant internal stakeholders
- Active role in the interpretation of legislation for the Saudi Region for the local business, as well as the GRA
- Implementation of existing legislation in working practices
- Scientific support to the business: Partner with legal, marketing, and technical teams to build a compliant claim strategy
- Cooperation with business in the development of promotional materials
- Signing off promotional materials as per the scope of responsibilities
REGULATORY AFFAIRS ASSOCIATE MANAGER
RECKITT
11.2021 - 03.2024
- Reckitt's Saudi Joint Venture Champion
- Providing regulatory expertise for the Saudi Joint venture and all related responsibilities
- Delivering the regulatory and safety strategy for new products or existing products, Management of any new registrations, and product license maintenance activities through the JV legal entity
- Registration and maintenance of Reckitt products within the JV scope
- Extend support to Saudi business where applicable for new product registration, localization, license transfer, local manufacture, and others
- Regulatory intelligence - legislation, competition: Monitoring of emerging legislation changes affecting Saudi business and communication to relevant internal stakeholders
- Active role in the interpretation of legislation for the Saudi Region for the local business, as well as the GRA
- Implementation of existing legislation in working practices
- Scientific support to the business: Partner with legal, marketing, and technical teams to build a compliant claim strategy
- Cooperation with business in the development of promotional materials
- Signing off promotional materials as per the scope of responsibilities
REGULATORY AFFAIRS SENIOR OFFICER
SAJA PHARMACEUTICAL
01.2020 - 09.2021
- SFDA & MENA region
REGULATORY AFFAIRS OFFICER
SAJA PHARMACEUTICAL
01.2016 - 01.2020
- SFDA & MENA region
- Preparing eCTD files for new products registration (Module 1 to 5), Renewal, variation or shelf life extension, transfer to electronic submission - EXTEDO software, liaison with company agents in GCC & MENA region, reply to SFDA and competent authorities inquiries, communicate with different plant department(R&D, QC, production) to prepare needed documents
REGULATORY AFFAIRS SPECIALIST
JAMJOOM PHARMA
01.2016 - 12.2016
- Preparation documents for registration, re-registration and variation of pharmaceutical products at the international market
- Review product promotional materials, labeling, batch records, specification sheets methods for compliance with applicable regulations and policies
- Communicate with regulatory agencies
- Maintain current knowledge base of existing emerging regulations, standards, or guidance documents
QUALITY CONTROL EXECUTIVE
JAMJOOM PHARMA
01.2014 - 01.2016
- Maintain regulatory compliance through established programs for sampling, Calibration, sample processing, laboratory testing (physical, HPLC, Dissolution) release, related documentation, Validation, cleaning Validation and other related Quality Control functions in respect of Finished Goods
Education
B.S. - BIOCHEMISTRY
King Abdul-Aziz University
MASTER OF BUSINESS ADMINISTARTION (MBA) -
Saudi Electronic University in association with Colorado State University- Global campus
Skills
- Technical dossier compilation
- Product registration
- Regulatory intelligence
- Audit and inspection readiness
- GxP standards proficiency
- Legislative interpretation
- Product labelling oversight
- Leadership capabilities
- Science degree
- Regulatory compliance
- Regulatory strategy
- Change control systems
- Risk Management
- Electronic Common Technical Document (eCTD) submission
Languages
Arabic
Native
English
Fluent
Personal Information
Nationality: Saudi
Certificates & workshop:
- Herbal & Health Products Workshop, 10/30/23
- SFDA e-SDR workshop, 10/18/23
- Pharmaceutical and Herbal products advertisements workshop, 09/07/23
- SFDA Cosmetics workshop, 09/05/23
- Finance for non-Finance, 08/28/23
- GHC workshop for e-PIL through QR codes, 06/05/23
- Agility in people management - Hygiene Regulatory Training Programme (RTP), 04/27/23
- Regulatory Ingredient Strategy: from intelligence to action plan - Hygiene Regulatory Training Programme (RTP), 02/10/23
- Introducing the rules of classifying the risk of medical devices, 01/17/23
- The 3rd Cosmetics standard meeting - GSO FDS 1943:2022, 10/20/22
- Endocrine Disruptors - Hygiene Regulatory Training Programme (RTP), 07/21/22
- GSO 2055- 2:2021 the updates on Halal certificates Standard, 07/11/22
- The Importance of Trust- Leadership Capability Building- Hygiene Regulatory Training Programme (RTP), 06/29/22
- Cosmetics claim evaluation service, 06/15/22
- Patency procedure during pharmaceutical products registration, 05/23/22
- Stability Testing for Drug Substances and Drug Products Workshop, 05/24/22
- Building your personal boardroom - Hygiene Regulatory Training Programme (RTP), 05/19/22
- Workshop for Biosimilars: from Development & Regulatory Perspectives, 05/18/22
- The role of Specifications in complying with technical requirements for marketing authorization, 02/28/22
- Cosmetovigilance in Saudi Arabia, 12/01/21
- Product Information file (PIF), 11/29/21
- Clearance Requirements for cosmetics products and the common reasons for rejecting shipments, 11/18/21
- MENA Pharmaceutical Manufacturing Series- CPD Certificate, 06/29/21
- Post marketing Drug Safety Compliance: 2019 Inspection Finding Webinar, 04/29/20
- Generic Drug Forum 2020, 04/15/20
- Excel For Business Workshop - Jeddah Excel Community, 08/21/19
- Generic drug formulation and Bioequivalence challenges, 05/26/19
- Affordability and Accessibility to Medicine- SFDA Conference, 09/01/18
- Pharmaceuticals Manufacturing Challenges in Saudi Arabia and how to overcome them, 09/01/18
- Cosmetics Regulation and Safety Evaluation, 09/01/18
- Clinical trials, innovation & Market access: Regulatory view, 09/01/18
- The SFDA Annual Conference, 09/25/18
- Drug Development, 05/01/17
- Drug Discovery, 04/01/17
- Good manufacturer Practice training, 01/01/16
Timeline
REGULATORY AFFAIRS & SAFETY ASSOCIATE MANAGER PERSONAL CARE
RECKITT
03.2024 - 04.2025
REGULATORY AFFAIRS ASSOCIATE MANAGER
RECKITT
11.2021 - 03.2024
REGULATORY AFFAIRS SENIOR OFFICER
SAJA PHARMACEUTICAL
01.2020 - 09.2021
REGULATORY AFFAIRS OFFICER
SAJA PHARMACEUTICAL
01.2016 - 01.2020
REGULATORY AFFAIRS SPECIALIST
JAMJOOM PHARMA
01.2016 - 12.2016
QUALITY CONTROL EXECUTIVE
JAMJOOM PHARMA
01.2014 - 01.2016
B.S. - BIOCHEMISTRY
King Abdul-Aziz University
MASTER OF BUSINESS ADMINISTARTION (MBA) -
Saudi Electronic University in association with Colorado State University- Global campus
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