CMC Regulatory Manager, External Manufacturing CHC, ASEA & AMET
Sanofi
- Cairo
- Permanent
- Full-time
- 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.
- 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.
- 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.
- 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.
- Preferably 10 years working experience in CMC regulatory affairs.
- 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.
- 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
- Preferably Degree in Pharmacy / Pharmaceutical Science / Related Science