Senior Regulatory Affairs Specialist
KSA and Bahrain
Total des années d'expérience :13 years, 4 Mois
Significant Highlights:
Proved instrumental in enabling operational excellence to release products blocks efficiently.
Created a dynamic work culture and communicate with local and regional marketing teams and distributors to
ensure the products are registered according to their launching plan and ensured they have all the necessary
regulatory documents.
Built a relationship with the authorities to communicate and facilitate approvals and discussed regulatory issues
with the global projects leaders to initiate corrective actions.
Key Responsibilities:
Compiled and maintained regulatory documentation databases and systems. Evaluated product complaints and
made recommendations regarding their reports.
Took follow-up regarding field Safety Corrective Actions initiated by Covidien with distributors and close them with
the competent authority.
Handled all administrative tasks for SGH tenders in addition to submissions.
Prepared and submitted the needed regulatory certificates to the competent authority to ensure that all the
products needed marketing authorization and made sure registration certificates were valid and renewed
whenever expired.
Communicated with regulatory agencies regarding pre-submission strategies, potential regulatory pathways,
compliance test requirements, or clarification and follow-up of submissions under review.
Provided technical review of data or reports that will be incorporated into regulatory submissions to assure
scientific rigor, accuracy, and clarity of presentation.
Reviewed product promotional materials, labelling, batch records, specification sheets, or test methods for
compliance with applicable regulations and policies.
Almarai Company
(Research & Development)
Significant Highlights:
Provided adequate advice in case of changes, ensured the countries got approval from authorities with
compliance of the regulation before launching the product in the market.
Successfully created product briefs, attended important meetings related to regulations, provided Regulatory
Support for the local co-packer activities that requires meeting with the authorities and more.
Actively engaged in speeding the launch of innovative products with claims in nutrition, Health and Wellness
including registration in the market and met the authorities
Customized the regulatory dossier, initiated meetings with Marketing and answer inquiries from CRS.
Key Responsibilities:
Ensured all claims are appropriately substantiated and documentation maintained.
Collected samples of all existing products to check the compliance with the labelling regulations, shelf life,
colorant, food additives and more.
Took regular follow up with the marketing team for any new developed product and checked the compliance with
local regulations in terms of label declaration, ingredients approval, colorant, food additives and shelf life.
Monitored the development of new and proposes rules, regulations and enforcement activities impacting the use
of ingredients, safety, labelling and advertising and new business models.
Extended adequate assistance to help the company against challenges by Enforcement (Port Health Authorities,
Food Control Authorities, Customs, and Chamber of commerce etc.) and competitors.
Compiled a file that contained contacts of the authorities and their roles and their personalities to deal with them
and assisted in Technical Translation Arabic /English for urgent request.
Boston University, USA |
courses: Internship in Medical Labs (Medical Laboratory) from Children and Maternity Hospital, KSA
