Regulatory Affairs Specialist or Senior Specialist, CMC or Submission Manager

Shape the future of regulatory excellence.
At IQVIA we partner with leading global biopharma organizations to drive smarter faster and more efficient regulatory pathways. We are now expanding our Regulatory Affairs team to support one of our key strategic partnerships and are looking for experienced Regulatory Specialists and Senior Specialists with expertise in either CMC or Submission Management.

(CMC or Submission Management focus)
Location: Egypt
Contract type: Permanent Hybrid role

Why Join IQVIA Regulatory Affairs

Youll be part of a team that blends deep scientific medical and regulatory knowledge with advanced technology and datadriven processessupporting global customers across the entire product lifecycle. Our brand ethos emphasizes innovation scientific rigor partnership and a unified consistent voice across all touchpoints.

At IQVIA every role contributes to improving patient lives worldwide. We empower our people with tools a strong identity and a collaborative culture that reflects our master brand: insightdriven hightech and humanfocused.

About the Roles

We are hiring across two primary focus areas:

1. CMC Regulatory Affairs

As a CMC RA Specialist or Senior Specialist you will:

• Prepare review and maintain CMC documentation throughout development and lifecycle management.
• Support CMC variations renewals and postapproval changes.
• Lead or contribute to CTD Module 2 & 3 content preparation coordination and quality checks.
• Drive regulatory CMC strategy engage with internal stakeholders and support health authority interactions.

2. Submission Management (Publishing / Lifecycle / Coordination)

In a Submission Managertype role you will:

• Plan compile format and publish regulatory submissions (eCTD & other HAspecific formats).
• Coordinate crossfunctional input and ensure submissions are delivered on time and in compliance with global standards.
• Support lifecycle submissions manage document flow and troubleshoot technical issues.
• Ensure alignment with evolving authority requirements leveraging IQVIA best practices and technologyenabled workflows.
  (Aligned with IQVIA publishing and regulatory operations guidance.)

What You Bring

Depending on level (Specialist or Senior Specialist):

• 2-5 years of experience in Regulatory Affairs within biopharma CRO or similar environment on European market.
• Specific experience in CMC and/or regulatory submissions (SM) is required.
• Knowledge of global regulatory frameworks and handson involvement with CTD eCTD variations renewals and dossier maintenance.
• Strong organizational skills attention to detail and the ability to manage multiple tasks in a fastpaced environment.
• Clear concise communication aligned with IQVIAs brand voice: insightful collaborative and human.

What We Offer

• The opportunity to work with leading experts across regulatory strategy CMC publishing intelligence and lifecycle management.
• Access to IQVIAs advanced tools templates and processes reflecting our consistent visual and narrative identity.
• Global project exposure in a collaborative environment that values scientific excellence innovation and continuous learning.
• A culture where your career can grow - across technical expertise leadership or crossfunctional pathways.

Ready to Make an Impact

If youre passionate about Regulatory Affairs - whether your expertise lies in CMC or Submission Management - and want to contribute to meaningful global work wed love to hear from you. Apply now to learn more about how you can grow your career at IQVIA.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at