At Gnosis by Lesaffre, we are looking for a talented, dynamic, and motivated Regulatory Affairs Specialist to support the expansion of our business. You will be responsible for the regulatory compliance of our product portfolio and play a critical role providing strategic advice on regulatory risks and opportunities to support market growth and innovation.
Responsibilities
* Ensure compliance of assigned Gnosis’ product portfolio with local regulations
* Manage timely regional registration activities, including registration dossier preparation and proper documentation of submitted documents
* Execute regional regulatory strategies in line with the global strategic plan
* Provide regulatory guidance and advice to internal stakeholders (e.g. marketing, R&D)
* Conduct regulatory watch and monitor changes in local legislation landscape, assess the impact towards Gnosis’s product portfolio and communicate accordingly to internal stakeholders
* Build effective working relationships with internal stakeholders
* Work closely with regulatory colleagues to maintain knowledge in local regulations and product-specific regulatory requirements
* Maintain full awareness of regulatory activities of assigned portfolio and provide regular reports
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