# Regulatory Affairs Manager – EU CMC Lead

**Company**: IQVIA
**Location**: New Cairo
**Experience**: senior
**Job type**: full-time
**Category**: Consulting
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/New-Cairo-Egypt/Regulatory-Affairs-CMC-Manager--Europe-CMC-Lead_R1579246?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/regulatory-affairs-manager-eu-cmc-lead-be0bc348-1af/

## Description

We are looking for an experienced Regulatory Affairs Manager – EU CMC Lead to provide regulatory CMC leadership across complex client programs.

In this role, you will lead CMC regulatory activities from planning through delivery, working with cross-functional and global teams including Regulatory CMC colleagues, Technical SMEs, dossier authors and submission teams.

You will provide regulatory guidance, coordinate key deliverables and timelines, manage risks, and act as a trusted regulatory partner to clients.

You will also contribute to new business opportunities, supporting proposals, client presentations and bid defenses from a Regulatory CMC perspective.

## Key Responsibilities

- Lead the planning and delivery of complex CMC regulatory activities across products, dossiers and markets.

- Provide regulatory CMC guidance on dossier requirements, CTD/Module 3 content and Health Authority expectations.

- Review CMC documentation from development, manufacturing and technical teams from a regulatory perspective.

- Coordinate CMC deliverables, timelines, dependencies, risks and responses to Health Authority questions.

- Lead cross-functional teams in a matrix environment, ensuring clear responsibilities, priorities and accountability.

- Facilitate CMC project meetings, document reviews and resolution of technical and regulatory comments.

- Act as a key client-facing Regulatory CMC contact, providing clear updates and regulatory recommendations.

- Translate client requirements into practical delivery plans, timelines and resource needs.

- Support RFPs, proposals, scope development, resource estimates, client presentations and bid defenses.

- Proactively identify project, quality, capacity and timeline risks and develop appropriate mitigation plans.

- Provide guidance and support to less-experienced team members.

- Support effective use of regulatory document-management systems, including Veeva Regulatory Vault.

## Qualifications

- Degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Biotechnology or another relevant scientific discipline.

- Typically 5+ years of Regulatory Affairs/CMC experience, including responsibility for complex CMC activities.

- Strong knowledge of EU CMC regulatory requirements, MAA dossier structures, CTD and Module 3.

- Experience supporting regulatory dossiers and responses to Health Authority questions.

- Good understanding of pharmaceutical manufacturing, controls and their regulatory implications.

- Demonstrated experience leading projects and cross-functional teams in a matrix environment.

- Strong project-management, planning, risk-management and problem-solving skills.

- Strong client-facing communication and stakeholder-management skills.

- Experience supporting proposals, RFPs, new business opportunities, client presentations or bid defenses is highly desirable.

- Experience with regulatory document-management systems; Veeva Regulatory Vault experience is an advantage.

- Ability to manage multiple projects and priorities while working effectively across global teams.

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## Skills

### Required
- Pharmacy
- Chemistry
- Pharmaceutical Sciences
- Biotechnology
- EU CMC regulatory requirements
- MAA dossier structures
- CTD
- Module 3
- regulatory document-management systems
- Veeva Regulatory Vault
- project management
- risk management
- problem-solving
- client-facing communication
- stakeholder management

### Nice to have
- proposals
- RFPs
- new business opportunities
- client presentations
- bid defenses
- Veeva Regulatory Vault experience

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