RA Associate

Job description / Role

Workforce Solutions has been engaged by our client to source an RA Associate.
As an RA Associate in Pharmaceuticals, you will provide effective regulatory support for the MENA region on NTO variation activities.

Preferred Skills / Experience:

• Supporting Regulatory Affairs in the preparation of variation packages for NTO-related variations
• Supporting Regulatory Affairs in the submission and approval of variations according to the plan
• Ensuring proper handling of the variations-related information in the regulatory systems, like DRAGON, according to KPIs.
• Handling HA queries and facilitate the preparation of responses to HA within the specified time
• Ensuring proper communication regarding the approvals and implementation of variations with relevant stakeholders
• Maintaining the archives of the variation dossiers in proper systems
• Ensuring clear and timely communication with internal and global stakeholders
• Ensuring an optimal supply regulatory process
• Addressing manufacturing site queries concerning shipment approval, authorisations and pre-license sale
• Coordinating with logistics, supply chain, artwork teams and manufacturing sites to obtain valid artworks and implementation dates
• Coordinating with logistics, supply chain, artwork teams and manufacturing sites to ensure that the registered product specifications are compliant and being imported to the country
• Supporting QA for batch release as needed

Requirements

• The ideal candidate must hold a degree in Pharmacy and have 1-2 years of industry experience dealing with a wide variety of registration projects and issues.
• Excellent English (oral and written) and interpersonal skills are mandatory. Must be computer literate with a proven track record in planning and execution.

About the Company

Transguard Workforce Solutions delivers Professional Contract Staffing (also known as Employee Outsourcing) within the UAE.

Our Workforce Solutions include:

• Delivering Sourcing and Recruitment Solutions for Clients in need of identifying Contract or temporary Staff.

• Providing a complete end to end Staffing Solution which includes Visa Sponsorship, HR Management, Employee Welfare & Payroll Services.

• Transitioning Contract Staff from other staffing providers to Transguard while remaining compliant with UAE Labour and Immigration Laws.

Transguard Workforce Solutions currently employ over 2000+ Staff from over 70 different nationalities. Across the Group, we payroll over 70,000 employees monthly.