Regulatory Affairs Specialist - English Speaker (8 Months Contract)Posted 16 days ago
91Applicants for1 open position
- 0In Consideration
- 0Not Selected
Skills And Tools:
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.
- 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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