.Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.ClinChoice is searching for **Senior** **Regulatory Affairs Associate Consultant** to** **join one of our clients.**Main Job Tasks and Responsibilities**:- Creation of regulatory strategies with the client regulatory team to guarantee approval by the Ministry of Health.- Support in the creation of a high-performance team to carry out the necessary activities in the designated project by the client regulatory team.- Lead the team of consultants to meet the project objectives- Preparation, compilation, and coordination of high-quality regulatory submissions for new product launches, product updates, and throughout product lifecycle.- Ensure that documents to be submitted to health authorities are ready by ensuring quality review is performed before forwarding to client regulatory personnel.- Support for CMC dossier preparation and review- Review of artwork changes and associated change controls, including tracking of deliverables.- Monitoring of new and changing regulatory standards and dissemination of information.- Support coordination of label change initiation, label reviews and changes in accordance with regional /country review system and procedure.- Provide regulatory input, review and approval related to change control- Support product portfolio through execution of legal document activities as required- Coordination with cross functional teams for collating labels and COA's of API, excipients and finished p- Coordination with cross functional teams, manufacturing site and local affiliates for the required information to process the documents- Search different internal tools for the required information to process the documents.- Preparation and compilation of regulatory documentation for submission to local country- Develop and manage regulatory action item tables for country specific requirements- Mapping, coordination of regulatory inputs and timing end to end for country requirements resulting from legal entity change e.G., documentation required, timelines for registrations/notifications and phase-in of changes to meet compliance requirements- Communicate internally and monitoring deliverables ensuring country requirements are met by specified timeframes- Record and publish meeting notes. Incorporate follow-up items to project deliverable tracking, ongoing monitoring, and issue escalation to client local managers