Regulatory Affairs Specialist - English Speaker (8 Months Contract)

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.