Regulatory Affairs Manager, Middle East Region

4 days ago


Dubai, United Arab Emirates Gilead Sciences Full time

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

**For Current Gilead Employees and Contractors:
**Job Description**:
**Responsibilities**:
**_Primary responsibilities
- **
- **Contributes actively to preparation and submissions, in collaboration with IC/GPS RA liaisons and local distributors, and cross-functional team, in line with national requirements and company policies and procedures.**:

- **Ensures execution of the registration plan for assigned products and territories, in collaboration with IC/GPS RA Liaisons & local distributor.**:

- **Ensures maintenance of registered products in coordination with IC/GPS Liaisons, 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**:

- **Builds effective relationships with local distributors.**:

- **Ensures consistent communication to internal/ external stakeholders, local distributors & partners**:

- **Performs all required reporting obligations
**_Labelling and Packaging
- **
- **Provides regulatory support to development and/or revision of product labeling in accordance with local requirements and in alignment with company policies and standards.**:

- **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.**:

- **Ensures implementation of serialization project and Track & Trace system, in collaboration with relevant internal & external stakeholders**:

- **Reviews of Arabic translations and Artworks, as needed
**_Regulatory Intelligence
- **
- **Maintains knowledge of regulatory requirements up to date and communicates changes to project teams and senior management in a timely manner.**:

- **Gathers, assesses & communicates Reg Intelligence & associated impact on Gilead’s products & activities in the assigned territories.
**_Regulatory Compliance, Quality & Pharmacovigilance
- **
- **Ensures regulatory compliance with local regulations, guidelines and practices.**:

- **Implements Gilead’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.**:

- **Acts as a Deputy Pharmacovigilance Responsible Person (PRP)**:

- **Liaises with Global Patient Safety and IC/GPS liaisons regarding submission & tracking of urgent safety restrictions, safety signals and notifications, when required.
**_Access / commercial cross functional support
- **
- **Provision of guidance and assistance to Gilead commercial team, for assigned products and territories, during preparation of promotional materials**:

- **Review of promotional & non-promotional materials and activities in accordance with national legislation and Codes of Practice and company policies and procedures, & coordinate submission & Health Authority approval, where required.**:

- **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.
**Skills and Requirements**:

- **Able to articulate complex regulatory affairs issues.**:

- **Must be knowledgeable of regional requirements for assigned territories.**:

- **Work is performed under limited direction.**:

- **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.**:

- **Excellent teamwork skills.**:

- **Must be able to facilitate effective interactions within IC/GPS RA team and with other departments and sites within the company.**:

- **Fluent English and Arabic language would be an advantage
**Knowledge, Education and Experience**:

- **BSc. of Pharmacy or Degree in a scientific field**:

- **5+ years of relevant experience in Regulatory Affairs**:

- **Experience of working within a Global R&D based pharmaceutical company
**Equal Employment Opportunity (EEO)**:It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if



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