Global Regulatory Affairs Manager – Pharma Submissions

IQVIA; Dubai; On-site; AED 250,000 - 500,000; Full time

Job summary

IQVIA in Dubai seeks a Regulatory Affairs professional to manage local submissions, labeling, and artwork approvals for designated markets. You will coordinate with stakeholders to ensure timely approvals and maintain compliance across markets.

The role requires experience with variations, renewals, and MAH transfers, plus strong English communication and Arabic fluency. You will lead junior colleagues and collaborate with global teams on lifecycle maintenance.

Qualifications

• Experience in regulatory processes across Chemistry Manufacturing & Controls.
• Experience with variation/renewal filings and artwork approvals.
• Strong English communication; Arabic fluency is required.
• Ability to lead regulatory teams and train junior colleagues.

Responsibilities

• Manage local regulatory submissions with internal/external stakeholders.
• Submit renewals/variations/new applications/MAH transfers to authorities and EMA.
• Prepare local product labeling in local language; review artwork.
• Manage multiple products and act as regulatory SME.
• Lead complex projects and deliver regulatory documentation.
• Provide guidance and training to teammates; present to clients.

Skills

Regulatory knowledge

Interpersonal communication

Organizational skills

English fluent

Arabic fluent

Team leadership

Adaptability

Education

Master's degree in Life science or related discipline

Job description

IQVIA in Dubai seeks a Regulatory Affairs professional to manage local submissions, labeling, and artwork approvals for designated markets. You will coordinate with stakeholders to ensure timely approvals and maintain compliance across markets.

The role requires experience with variations, renewals, and MAH transfers, plus strong English communication and Arabic fluency. You will lead junior colleagues and collaborate with global teams on lifecycle maintenance.