Job description / Role
Leading the Regulatory Affairs matters in MENA region ensuring compliance of products and processes with countries legislation and rules.
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 and concerned government authorities.
• Obtain launch and re-launch samples and packaging.
• 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 SOP’s per country.
• Establish contacts with local authorities and act as primary contact for regulatory issues.
• Follow-up with distributors and concerned government authorities for complete registration application approvals, and ensure successful in-market product launch.
• Review product regulatory compliance and approve artworks for Cosmetics, Medical Device and Cosmeceuticals.
• Manage artwork claims by communicating internally with Global Regulatory and R&D, collecting supporting documents to the government authorities.
• Ensure local product handling activities (packing/ repacking, storage, promotion activities, and sampling) adhere to regulatory requirements.
• Ensure full regulatory compliance for 3PM-products sourced under local responsibility (e.g. “local beauties”) and locally sourced promotion articles.
• Responsible for lab testing and required analyses.
• Participate in supply chain academies for distributors.
• 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).
• Multinational Company Business Group (MCBG) weekly meeting attendance.
• Monthly meetings with Marketing and Demand/Supply Planners (triangle meeting).
• Attend monthly meetings with distributors to ensure smooth operations.
• 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 new 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 HQ Formula and Regulatory team on any administrative projects.
• Monitor regulatory developments and requirements / recommendations on country level and communicate important issues to Corporate Quality Management (Market Compliance, External Relations).
• Provide information on local requirements upon request of QM Market Compliance within IIM (e.g. product classification, regulatory clearance, specific packaging requirements).
• Represent Beiersdorf in the authorities meetings and the national industry associations in conjunction with External Relations.
Documentation and Reporting system:
• Maintain and update Regulatory Library with copies of all country registration files (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.
• 3-5 years’ experience in Regulatory Affairs, preferably with an FMCG/ pharmaceutical company - cosmetics an asset.
• Local knowledge of Middle East regulations for cosmetics, medical devices, pharmaceutical products.
• Strong verbal and written communication skills in English and Arabic – mandatory.
• Proficiency in MS Office applications, mainly Excel and Word.
• Experience with MS Access or another database program advantageous.
• Mandatory SAP knowledge.
• High attention to detail and rigorous accuracy.
• Insightful, with strong analytical skills and the ability to consolidate complex information, interpret & develop strategies, tactics and measurable implementation.
• Ability to work with governmental organizations.
• Strong research skills to compile and present complex and technical arguments to governmental authorities.
• Interpersonal skills capable of building strong working relationships and influencing others in a multi-cultural environment using a consultative approach.
• Results oriented, entrepreneurial and self-motivating.
• Must have proven ability to be flexible, multi task and drive key projects in a fast paced, high demand environment.
• Confident and capable of operating and presenting at all levels, good team player and Company representative externally.
• Tenacious and resilient, driven to achieve and takes initiative to handle and resolve issues independently and quickly when faced with obstacles.
• Strong sense of urgency with ability to drive business critical projects; can work independently under general direction.
• Problem solving and decision making skills, with an ability to think outside the box.
About the Company
Every day, our global brand icons, such as NIVEA, Eucerin and Hansaplast, make more than 500 million consumers in over 70 countries feel good in their skin. Care for consumers and our people worldwide is what has driven us all the time. More than 130 years ago, we invented modern skin care, kept continuously innovating it and still have a clear business focus on it. This is what has made us today's No.1 skin care company in the world. Across the Middle East and North Africa, our brands hold many no. 1 market positions. We strive to reinforce these positions by growing in strategically selected markets and convincing our customers by continuously providing the latest product innovations. In this regard, we continue to count on intensive research, state-of-the-art technologies, perfect marketing strategies and above all our competent and dedicated employees.
Learn more about us and our job opportunities on our LinkedIn company page and our website - Join Beiersdorf!