29/06/2022
We are hiring :
Regulatory Affairs Supervisor (GCC Market)
ROLE PURPOSE:
Drive all aspects of in-market regulatory affairs operation for the existing and new marketing authorizations.
Be active part of the organization and ensure proactive alignment with internal and external stakeholders, act as key interface between Riyadh pharma and local regulatory authorities.
• Responsibilities:
- Handling all regulatory activities with Regulatory team
- Acts as responsible Regulatory Team member for assigned regulatory projects�- Preparation and filing of submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, and publishing.�- Prepares and/or reviews regulatory documentation in line with assigned timelines.�- Support the strategic and operational planning.�- Understands the Scope of Work, timelines and deliverables for a given project�- Prepare status reports and metrics for assigned projects�- Ensuring compliance with regulations set by each country authority.�- Maintaining familiarity with company product ranges
- Liaises with the local health authorities and local distributors with regards to all regulatory affairs related issues
-Updates the company with the most recent registration requirements and procedures for manufacturer’s and products in GCC Markets.
-Ensure Regulatory Labelling compliance for Labelling & Packing
-Provide an assessment of the impact of new and changing& predict changes in regulation.
-In collaboration with team provide regulatory strategies, regulatory guidance and advice on each local country regulatory environment.
- Learn, develop and train.
• Qualifications/Experience:
- BSc / Pharmacy degree�- 5-7 years’ Experience in Similar RA position in GCC region, with high knowledge of SFDA & GCC regulations, preferable experience with various HA in GCC region.�- Understanding of Regulatory strategy and determination of documentation requirements.�- Using a variety of specialized computer applications e.g. Microsoft Excel, PowerPoint, eCTD, QMS, …etc.�- Previous Experience in DMF reviewing & vendor qualification is preferable.�- Solid problem solving skills�- Ability to work independently and under pressure�- Organizational, follow up and time management skills
• Languages
- Fluency in English and Arabic, both spoken & written.
To apply : [email protected]