Job Description
The Regulatory Specialist is responsible for ensuring compliance with
local and international regulatory requirements related to the registration of
pharmaceuticals and medical devices. The role involves preparing and submitting
registration dossiers of both
manufacturing sites, MAHs and products, following
up with the Ministry of Health and relevant authorities, reviewing promotional
materials, and maintaining updated records.
Key Responsibilities
- Prepare and submit regulatory dossiers to health authorities (handling the uploading of the dossiers on Soft-Max)
- Follow up on registration processes and communications with MOH and other authorities.
- Review promotional and marketing materials for compliance with regulations.
- Maintain updated records of registered sites, MAH and under-registration products.
- Support Marketing and Operations teams with regulatory information when needed.
- Ensure sustained importation to Kurdistan by prior completing the Import permit for normal and Narcotic products and registration of both site, MAH and products within specific timelines.
- Responsible for all PV reports required with the regulatory authorities.
Qualifications
- Bachelor’s degree in pharmacy or a related field.
- Minimum of 2 years of experience in pharmaceutical regulatory affairs.
- Good knowledge of Iraqi MOH regulations and requirements.
- Proficiency in English (reading, writing, speaking), with a good command of Kurdish.
- Strong organizational and communication skills.
- Experience in registration of both pharmaceuticals, Supplements and medical devices.
- Professional correspondences.
Preferred Qualifications
- Certification or training in regulatory affairs.
- Experience in multinational or regional pharmaceutical companies.
- Very good in MS office
Personal Attributes
- High attention to detail.
- Ability to work under pressure and meet deadlines.
- Team spirit and collaboration with other departments.
- Proactive and agile/ Problem Solving.