Our Client a leading Pharma company is looking for a Regulatory Affairs Specialist.
This is a contract role under ManpowerGroup - 12 months renewable
• Direct Report to Regulatory Gulf Team Leader
• Works closely with Regulatory Senior Associate teams in country and other stakeholders
Position Purpose
The Regulatory Specialist will support the development of the strategic direction and work closely with Country based Regulatory teams and above country regulatory teams to develop and execute regulatory strategies and plans for the country.
Primary Responsibilities
• Support the local Regulatory team in the development of regulatory strategies to support the registration of new products, line extensions, major variations and lifecycle management. Provide strategic regulatory input to support for meeting local business objectives.
• Develop strong partnerships with in-country (e.g. Market Access, Marketing, Supply Chain) and with above country (e.g. Country Strategists, GCMC, Submission and labeling/artwork Hubs) to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Responsible for their own personal development, leadership and performance to achieve company objectives and agree training and development needs with Regulatory Gulf Team Leader to develop and enhance individual capabilities and capacities
• Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product.
• Effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies.
• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems are followed ensuring training are completed 100% (systems and procedures).
• Maintain compliance (Systems, CMC change control, product labelling, etc.) at 100%.
• Where needed, oversee and manage the completion of NDA and Lifecycle (LC) submissions and approvals as per established performance metrics.
Job Details
| Posted Date: | 2018-11-04 |
| Job Location: | Dubai, United Arab Emirates |
| Job Role: | Administration |
| Company Industry: | Employment Placement Agencies/Recruiting |
Preferred Candidate
| Career Level: | Mid Career |
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