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| Title | Location | Description |
|---|---|---|
| Regulatory Affairs Manager (Contract) | Virtual | A multinational organization that researches and commercializes innovative therapeutics is looking to hire an experienced Regulatory Affairs Manager - Middle East Region based in Dubai. The person will be the first point of contact for all regulatory questions on one or more products across Middle East countries. Skills and Requirements - Must be knowledgeable of regional requirements for assigned territories. Work is performed under limited direction of a senior Regulatory Affairs professional. Plans, schedules and arranges own activities and may direct others in accomplishing objectives. Excellent organization skills and ability to work on a number of projects with tight timelines is required. Excellent verbal and written communication skills and interpersonal skills are required. Is recognized as a knowledgeable resource for Regulatory Advice on specific topics in other departments. Excellent teamwork skills. Must be able to facilitate effective interactions within International Regulatory Affairs and with other departments and sites within the company. Fluent in English / Arabic Knowledge, Education and Experience - BSc. of Pharmacy or Degree in a scientific field 5+ years of relevant experience in Regulatory Affairs or other relevant industry experience Experience of working within a Global R&D based pharmaceutical company would be an advantage Job Responsibilities - Regulatory submissions Contributes actively to preparation and filing of submissions, in collaboration with IRA and local distributor, which may require interaction with departments outside of Regulatory Affairs for assigned products and territories in line with national requirements and company policies and procedures. Reviews and advises on content of the registration files to fulfill local requirements and ensure smooth submission and review of the related application, as needed. Ensures execution of the registration plan for assigned products and territories, in collaboration with IRA team & local distributor. Ensures maintenance of registered products in coordination with IRA, logistic/ supply, commercial and local distributors in order secure supply continuity. Tracks and facilitates manufacturing sites registration in line with national requirements Updates and maintains registration status dashboard Labelling and Packaging Provides regulatory support to development and/or revision of product labeling (local labeling) in accordance with local requirements and in alignment with company policies and standards. Reviews of Arabic translations and Artworks, as needed Ensures Regulatory Labelling compliance and submission of safety updates in line with Health Authorities requirements & internal compliance deadlines. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Liaises with Global Pharmacovigilance & Epidemiology (PVE) and IRA regarding submission of urgent safety restrictions. Ensures implementation of serialization project and Track & Trace system, in collaboration with relevant internal & external stakeholders Regulatory Intelligence Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information to project teams and senior management in a timely manner. Gathers, assesses & communicates Reg Intelligence & associated impact on the company's products & activities in the assigned territories Regulatory Compliance & Quality Ensures regulatory compliance with local regulations, guidelines and practices. Implements company's SOPs and associated process documentation, as required. Acts as Records Retention coordinator for the appropriate maintenance and storage of information according to agreed records retentions schedules for regulatory affairs. Commercial support Provision of guidance and assistance to company's commercial team, for assigned products and territories, during preparation of promotional materials Review of promotional material and activities in accordance with national legislation and Codes of Practice and company policies and procedures. Supports tender requests & enlisting by coordinating through applicable channels in order to gather the related technical requirements on timely manner & maintain the related tracker accordingly. Communication Ensures consistent communication to internal/ external stakeholders, local distributors & partners Builds effective relationships with local distributors and Health Authorities based on transparency, trust, and respect Performs all required reporting obligations Project Involvement Provides Regulatory Affairs input to crisis and incident management and business continuity planning and events, as required. Contributes in local / regional process improvements initiatives Key Differentiating Contributions - Will liaise with local distributor and acts as a primary company's contact for all regulatory questions on one or more products across Middle East countries. Able to articulate complex regulatory affairs issues. |