Senior Specialist, Regulatory Affairs

ARA-P2-11

Job Purpose

• Responsible for dossier compilation and submission
• Responsible for ensuring compliant life cycle management in compliance with market regulations
• Manage local Labeling and AWs creation and submission  
• Maintain the regulatory processes within the department, including assist with the development and implementation of regulatory procedures and SOP,
• Manage Communication with regulatory agencies or related interface  

Key Responsibilities

1

• Working autonomously but in alignment with department to manage daily Regulatory Affairs activities and responsibilities while collaborating closely with various departments
• Provides regulatory information and guidance for proposed product claims/labelling;

2

• Supports the coordination, compilation, and submission of registrations for new products, renewal of registrations, life cycle maintenance and various variations submissions, respond to queries from health authorities and other correspondence in accordance with the authority's regulations and guidelines and the country specific requirements.
• Maintain current knowledge of existing and emerging regulations, standards and guidance documents.

3

• Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges by managing timelines and priorities for the regulatory submissions to meet business objectives
• Ensures compliance with markets regulations and registration procedures, training and educating internal stakeholders on regulatory requirements and updates
• Accurately maintain product information databases; (Veeva)
• Perform regulatory assessments, (change controls)

4

• Responsible for maintaining regulatory processes and systems to streamline operations and archive all regulatory documentation.

5

• Local development of packaging materials; writing clear, accessible product labels, patient information leaflet and products prescribing information leaflets in English, Arabic
• Creates and provides lifecycle management for Prescribing Information, Patient Labelling or packaging artwork (layout, mock-ups, production artwork). Provides regulatory review and acts as text approver through alignment between approved content and artwork

6

• Maintain artworks database and trackers (proposed, submitted & approved) and relevant internal SOPs for artworks creation, approval, maintenance and approval
• Launch/Implementation: Review final artworks, approve new or revised labelling to be implemented into production. Approve all change requests for revised labelling for assigned projects/products. Provide Supply Chain and QA guidance on labelling implementation requirements
• Manage translations and address discrepancies with local partners and linguistic experts, ensuring alignment with source content.

7

• Support projects for regional harmonization of products labelling and compliance with local regulations
• Interact with Regulatory International and regional Partners to ensure timely implementation of global labelling changes in local product information, international consistency with the company’s position defined in the CCDS, and compliance with local labelling regulations.
• Meet and coordinate regularly with supply chain team to plan labelling changes that may impact shipments.
• Implement safety and labelling changes and while being aware of upcoming shipments that may be affected by these changes. Alert relevant stakeholders team of upcoming affected shipments to work with health authorities ensuring smooth clearance.

8

• Perform other duties as assigned by the Direct Manager including but not limited to budget tracking and budget reconciliation, systems support and troubleshooting and promotional material support.

Qualifications

Education

Scientific Degree or equivalent regulatory affairs qualification / Bachelor of Pharmacy

Certifications or Designations

Bilingual English / Arabic

Project management skills

Experience

Appropriate Regulatory Experience – minimum 5 year’ experience

Knowledge and Skills

• Organized, attention to details
• Adaptability and continuous learning
• Team player
• Agility
• Resilience
• Best practices knowledge in Regulatory Affairs
• Compliance management

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