Global Regulatory Affairs Manager (homebased)

ROLE DEFINITION & RESPONSIBILITIES
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
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
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
IQVIA is a leading global provider of advanced analytics, technology solutions, and contract research services (CRO) to the life sciences industry. The company helps pharmaceutical, biotech, and medical device clients accelerate the development and commercialization of new medical treatments through its extensive data, technology, and human expertise. Their offerings span from clinical trial design and execution to real-world evidence and commercial effectiveness.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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