Senior Regulatory Affairs Associate Consultant

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.- Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing- Work with client regulatory managers to develop project implementation plans and manage workload planning to ensure on time completion of projects and tasks- Support client regulatory managers in their registration procedure- Complete market impact assessments- Generation of databases and checklists for project monitoring- Support in the creation of product history and archives- Company systems update**Deliverables**:- Provision of weekly updates (at a minimum) to relevant client regulatory managers- Ensure regulatory standards and timelines are met- Plan and track the status of ongoing regulatory projects- Regulatory action item tables for country specific requirements and importation/ exportation needs for change in legal entity- Presentation materials for management updates- Ensuring documents for health authority are submission-ready- Supporting coordination of label change initiation, label reviews and changes in accordance with regional /country review system and procedure.- Regulatory input, review and approval related to Change Control**Education and Experience**:- Regulatory professional with formal college or higher education in science related discipline- Relevant work experience with minimum 5+ years in regulatory affairs- Individuals must have fluency of English and local language.- Good understanding of local regulations for OTC, Cosmetics and Medical devices- Strong working knowledge of Microsoft Word, Excel, Power Point- Good communication and follow-up skills with country regulatory liaisons for clear understanding of country specific needs for registrations, license updates and import/export requirements.**The Application Process**:**Who will you be working for?****About ClinChoice**:ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.**Our Company Ethos**:Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercializa