Nairoukh Pharmaceuticals Group, a pharmaceutical manufacturer, has a vacancy for a Regulatory Affairs Manager in Amman to head its regulatory department. The post also includes serving as QPPV, which covers the collection and assessment of suspected adverse events.
About the regulatory affairs manager job in Amman
The regulatory department handles registrations for human pharmaceutical products, medical devices, herbal products, food supplements and vitamins, and the job includes improving how those registrations are handled. The workplace is on Al-Ordon Street in Amman.
Responsibilities
- Holds full responsibility for regulatory submissions, from compiling complete CTD and eCTD dossiers to filing them with the authorities
- Keeps current product registrations in force across the product lifecycle while building professional relationships with the authorities and spotting changes in legislation and regulations early
- Sees to compliance with drug safety reporting obligations (pharmacovigilance) and regulatory obligations, and serves as QPPV, collecting and assessing suspected adverse events
- Develops annual regulatory plans for each country with regional business development managers or partners, in line with business objectives
- Provides regulatory oversight, leadership and guidance to staff on day-to-day compliance with permits and regulations
- Updates the regulatory affairs systems with ongoing activities, timelines and priorities, and maintains resource documents such as SOPs and work instructions
- Gives cross-functional teams up-to-date product registration details
- Takes part in or supports internal and external audits, and joins vendor qualification and the initial evaluation of DMFs
How to apply
Applicants send their CV by email to the email address below.
Send your CV to: [email protected]
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