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A leading consumer healthcare company are hiring a Regulatory CMC Project Manager in France, UK, Netherlands or Ireland (flexible hybrid working) who will be responsible for the hands-on regulatory activities associated with bringing new products to the market across our markets outside the U.S, with focus on the EU.
As a RA Project Manager, you may also be responsible for supervision of direct reports.
Scope of the Role
* Lead Regulatory Affairs Projects; providing updates to business and reporting against project plans.
* Develop regulatory strategies for CMC aspects of new MAAs and NPD projects, identifying risks and opportunities.
* Complete due diligence on time for any assigned product dossiers, identifying risks and opportunities.
* Manage, coordinate and execute technically complex MA Variations e.g., Site transfer and Reformulation projects
* Support Change Controls – providing RA assessment, strategy and appropriate actions
* Support resolution and action related to artwork related issues
* CMC support for MDR related changes to the medicinal CTD
* CMC expertise and RA activity in support of emerging ingredient issues in compliance with related guidance
* Develop, roll out and maintain relevant internal procedures and best practices.
* Maintain the integrity of regulatory data in the relevant databases.
* Interpret and implement legislation, follow changes in national regulations and legislations and proactively manage impact of these changes
5 years experience in the field of regulatory affairs, with some supervisory experience. University Degree or equivalent required.
Must have strong experience in CMC and pharmaceutical life cycle management. Managed tech transfer & have CMC experience in manufacturing sites, R&D or QC labs. Good interaction skills with internal and external stakeholders. Ability to handle multiple complex projects in parallel, with high accuracy and attention to detail. Self-motivated, flexible and open to changing requirements.
Desirable to have experience in due diligence of dossiers and drug substances (3.2.S)