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Regulatory Affairs Specialist - ...

Target Recruitment & HR...
New Cairo, Cairo

Regulatory Affairs Specialist - English Speaker (8 Months Contract)

New Cairo, CairoPosted 16 days ago
91Applicants for1 open position
  • 0Viewed
  • 0In Consideration
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Job Details

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Job Description

Product Registration and Regulatory Compliance

  • Handle new product registrations, product re-launch registrations, product renewals, site registrations, marketing authorization holder registrations of cosmetics, medical devices, general sale list items and health products.
  • Transpose registration data and dossiers in their required format and language to submit information to authorities.
  • Plan for the appropriate timelines of receiving, dispatching and submitting all requested documents (legalized certificates, full dossiers ®istration samples) to distributors, external labs and concerned government authorities.
  • Coordinate orders for launch and re-launch samples.
  • Partner with relevant functional teams: distributors, production centers, health authorities, marketing affiliates, sales affiliates, and supply planners to ensure successful continuity of business.
  • Write and update SOPs per country.
  • Establish contacts with local authorities.
  • Follow-up with distributors and concerned government authorities for complete registration application approvals, and ensure successful in-market product launch.
  • Update and develop regulatory trackers with daily activities.
  • Review product regulatory compliance and correct/validate artworks for Cosmetics, Medical Device and Cosmeceuticals.
  • Manage artwork labelling elements and claims by communicating internally with Global Regulatory and R&D, collecting, validating supporting documents and regulations to the government authorities.
  • Partner with marketing team in assessing communication & testing protocols (TVC, advertisements, PIU).
  • Responsible for lab testing and required analyses.
  • Launch new brands in existing markets and introduce existing brands to new markets in the Region.


Regulatory Affairs Communication

  • Follow up on all regulatory affairs requests from HQ and production centers (PCs).
  • Monthly meetings with Marketing and Demand/Supply Planners (Triangle meeting).
  • Attend monthly meetings with distributors to ensure smooth operations.
  • Monitor regulatory developments and requirements/recommendations on country level and communicate important issues to MENA Supply Chain Team and Marketing.
  • Lead negotiations with authorities on product classifications, new registration systems and documents required, and draft letters addressing any company concerns/ challenges to the authorities.
  • Study regulations and highlight the impact on Company products.
  • Communicate with HQ and PCs for obtaining manufacturing site quality system certificates, certificates of free sale, and COA, GMP, and health certificates.
  • Support the Regulatory team on any administrative projects.
  • Provide information on local requirements upon request (e.g., product classification, regulatory clearance, specific packaging requirements).

Documentation and Reporting system

  • Maintain and update Regulatory Library with copies of all regulatory documents & country registration files (dossiers & registration certificates).
  • Build and update product data base.
  • Receive applications and set up the technical files.
  • Generate reports, summaries of regulatory data and information for presentations or special regulatory affairs projects.

Job Requirements

  • Pharmaceutical/Science Bachelor’s Degree or any related field. 
  • 1-2 years’ experience in Regulatory Affairs, preferably with an FMCG/ pharmaceutical company - cosmetics an asset.
  • Local knowledge of some MENA regulations for cosmetics, medical devices or pharmaceutical products.
  • Fluent English.
  • Strong verbal and written communication skills in English.
  • Proficiency in MS Office applications, mainly Excel and Word.
  • Experience with MS Access or another database program is advantageous. 
  • SAP Knowledge is an Asset.

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