CHC - External Manufacturing CMC Regulatory Manager, Asia and ATME- TOM_2740
date posted 02/25/2021
contract typeFull time
job id R2587625
Manage the CMC regulatory activities within the scope of External Manufacturing CHC Asia and ATME (Africa, Turkey & Middle East) in coordination with Sanofi Regulatory Affairs (Global Regulatory Affairs CMC, Sanofi affiliates local Regulatory Affairs, Regional Regulatory Affairs) and the third-party manufacturers located in this region. This position will report to the EM Quality and Compliance manager.
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 Participate in Project team and support technical task force meetings on RA/CMC related activities. Any ad hoc tasks assigned by the reporting Manager
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 timeline.
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 Domasys.
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.
Provide regulatory training to the third-party manufacturers.
Provide regulatory KPI’s and regulatory highlights to the reporting manager on a monthly basis.
Degree in Pharmacy / Pharmaceutical Science / Related Science
Experience & knowledge:
At least 8 years working experience in CMC regulatory affairs.
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.
Able to work independently and write technical reports.
In depth knowledge of ASEAN, ICH Guidelines and local market regulations.
CMC support of new and/or marketed pharmaceutical/nutraceutical/cosmetics products in Asia.
Computer skills: Word, Excel and Veeva systems (Regulatory tool for Dossier management, Registration database).
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