location Cairo, Egypt Position Title: CMC Regulatory Manager, External Manufacturing CHC, ASEA & AMET
Job Location: Egypt
Job Type: Permanent, Full time
At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.
In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.
Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
About the job:
Manage the CMC regulatory activities within the scope of External Manufacturing CHC AMET (Africa, Middle East & Turkey), ASEA (Southeast Asia, South Korea, Hong Kong & Taiwan) & AU (Australia) & in coordination with other Regulatory Affairs teams (Global Regulatory Affairs CMC, local Regulatory Affairs, Regional Regulatory Affairs) and the third-party manufacturers located in the region. This position will report to Lead, CMC Regulatory, External Manufacturing CHC AMEA & China Serve as functional Regulatory CMC representative of the Products manufactured by third-party manufacturers. Ensure the compliance of the products to the local regulations. Support CMC/RA key-point within the frame of the site transfer and new product developments (NPD)s. Participate in Project team and support technical task force meetings on RA/CMC related activities. Any ad hoc tasks assigned by the reporting manager.
Main Responsibilities:
Maintain the product licenses in compliance with the local requirements:
Life Cycle management: preparation of the Module 3 CTD dossiers as per the applicable regulation for renewals, new registrations, responses to the Health Authorities. Regulatory Compliance: gap analysis V.S the current dossiers and V.S the current ICH/ASEAN Guidelines. Regulatory variations preparation by using the regulatory tool Veeva. Change Control management: preparation of change control request form (CCRF), quality/regulatory assessment. Elaborate the regulatory strategy with Global Regulatory Affairs and local affiliates. Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits. Coordinate with Global Regulatory Affairs CMC, Sanofi affiliates local Regulatory Affairs to ensure timely and accurate submissions to Regulatory Authorities.
Is the key-point for all CMC RA topics within the scope transfer project
Collect the registered information from all markets. Collect the site documentations (batch records, QC working instructions, stability reports, batch analysis) from the sending site necessary to perform the gap analysis. Identify as early as possible, the required documentation and any content, quality and/or time-line issues. Negotiate the delivery of approved technical source documents in accordance with project time-line. Perform the variation record card (VRC): gap analysis of the current dossier V.S the donor site V.S the receiving site. Consolidate the regulatory strategy with the affiliate or the Global RA to submit the site change. Coordinate with the receiving site the specific activities to fulfil the requirements for each market such stability studies, dissolution, BE study, etc. Preparation of the CMC sections based on the documents provided by the third party manufacturer. Formatting of the CMC modules as per the sanofi requirements and creation of the CTD documents in Veeva. Response to MoH questions related the quality module of the dossier. Follow up of the regulatory status of the submissions. Provides RA CMC support to other Sanofi sites who will receive the products from third party manufacturer.
Is the key-point for all CMC RA topics within the scope of new product development
Support the cmc RA aspect of product due diligence. Share regulatory requirements to third party manufacturers. Review dossier to ensure compliance of dossier with local legislation where the product is to be marketed Co-ordinate with global, regional and local teams for the dispatch of the dossier Support response to queries for deficiency letters received. Provide regulatory training to the third-party manufacturers. Provide regulatory KPIs and regulatory highlights to the reporting manager on a monthly basis. Any ad hoc activities as specified by the reporting manager.
About you:
JOB-HOLDER REQUİREMENTS
Qualifications:
Preferably 10 years working experience in CMC regulatory affairs.
Technical skills:
Writing of technical reports, In depth knowledge of ICH Guidelines and local market regulations, Experience in providing CMC support of new and/or marketed pharmaceutical/nutraceutical products Ability to provide input, guidance and recommendations in the preparation of the dossiers from different sources to give uniformity of filing in each country.
Soft skills:
Ability to work in a matrix organization Good team spirit and familiar with project development through cross-functional activities Strong organizational and negotiation skills Ability to establish and maintain good regulatory networking internally and externally Strong interpersonal and communication skills (writing & verbal) with excellent command of English, Pro-active and well organized with good sense of responsibility Balanced Judgment / Risk based approach Analytical thinking, hands-on troubleshooting style
Education:
Preferably Degree in Pharmacy / Pharmaceutical Science / Related Science
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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