No visa or accommodation sponsorship
You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s)
As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients – global pharmaceutical companies.
JOB OVERVIEW
Essential Functions
•Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries
•Submit submissions such as renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and EMA and follow up on the local regulatory approval process for designated countries
•Preparation of local Product Labelling (e.g. SmPC, PIL), in local language for designated countries
•Artwork review and approval in client systems
•Manage multiple pharmaceutical products
•Act as subject matter expert in regulatory processes
• Acts as a Regulatory Team Leader on more complex projects, which may include authoring of regulatory documentation, filling application forms.
• Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned and discuss customer comments
• Acts as a Subject matter expert in Regulatory knowledge in Chemistry, Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.
• Project budget management
• Give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
• possible exposure to present to clients on complex regulatory processes bid defense meetings
• Act as reviewer for regulatory standard operating procedures
• Prepare and deliver internal regulatory training if required
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Experience
Typically requires 8-10+ years of prior relevant experience.
Education
Master's Degree in Life science or related discipline
Skills and Abilities
- Good understanding of the Research and Development process (Chemistry, Manufacturing &
- Controls) relevant regulatory guideline related guidelines
- Possesses a specific regulatory or technical expertise
- Interpersonal communication (oral and written) and organization skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Demonstrates self-motivation and enthusiasm
- Ability to adapt quickly to a rapidly changing environment
- Knowledge of Maintenance of marking Authorization
- Experience of preparing variation, renewal packages and artwork approvals.
- Fluent in English language and able to effectively communicate complex business language to those who speak English as a second language.
- Must be fluent in Arabic
#LI-Remote
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
Skills Required
- Master's Degree in Life Sciences or related discipline
- 8-10+ years of relevant experience
- Fluency in English and Arabic
- Good understanding of Chemistry, Manufacturing and Controls (CMC)
- Experience preparing variation and renewal packages
IQVIA Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
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Retirement Support — Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
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Leave & Time Off Breadth — Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.
IQVIA Insights
What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
