Senior Regulatory Affairs Specialist

About the Role

Pharmaceutical Solutions Industry is seeking an Asst. Manager – Registration to join their team in Makkah, serving both Jeddah and Makkah. This full-time role is critical for ensuring the timely registration of the company's products in local and export markets, encompassing Active Pharmaceutical Ingredients (APIs), excipients, and packaging materials.

Role Purpose and Context

The primary purpose of this position is to manage all registration actions and activities for PSI products. This involves navigating regulatory requirements for both the Saudi Food and Drug Authority (SFDA) and other international regulatory bodies, ensuring compliance and maintaining up-to-date product licenses.

Key Responsibilities

• Manage the electronic submission of Registration Files in eCTD format to SFDA and other regulatory authorities outside KSA.
• Review data within registration files prepared for submission to regulatory authorities.
• Oversee the life cycle management (registration, renewal, variation) of PSI products in accordance with SFDA and export countries’ regulations.
• Maintain a complete registration archive, including updating the status of registrations, renewals, and variations, and ensuring all licenses and labeling are current.
• Monitor applications for the SFDA market via the eSDR site.
• Coordinate and follow up with departments such as Quality Control (QC), Quality Assurance (QA), Production, and Research & Development (R&D) for data collection.
• Manage the review and response process for all documents related to APIs, excipients, and packaging materials, including the open part of API CTD and related documents in Change Control Proposals (CCPs) and Supplier Notification System Forms (SNSFs).
• Provide timely responses to queries and comments from SFDA and other regulatory authorities.
• Stay informed of international legislation, guidelines, and customer practices in all export countries.
• Represent regulatory affairs on the R&D product development project team to ensure all regulatory requirements are met throughout the development process.

Qualifications and Experience

• Candidates should possess 5-10 years of relevant experience in registration within the pharmaceutical industry.
• Demonstrated understanding of regulatory requirements for local and international markets is essential.

Work Environment

This is a full-time position based in Makkah, with responsibilities covering operations relevant to Jeddah and Makkah. The role involves close collaboration with various internal departments and external regulatory bodies.

Application Process

Salary details for this position will be disclosed during the interview process. Interested candidates are encouraged to apply.