Regulatory Affairs Consultant MENA Outside IR35

Your new company
We are partnering with a highly regarded regulatory affairs consultancy that is seeking an experienced Regulatory Affairs Consultant to support clients with strategic regulatory activities across the Middle East and North Africa (MENA) region.This is a senior-level role offering the opportunity to lead complex regulatory strategies, work closely with global project teams, and play a key role in lifecycle management and safety submissions across multiple markets.Your new role
The Regulatory Affairs Consultant MENA will be responsible for communicating and implementing regulatory strategies to support product lifecycle management (LCM) and ensure compliance with evolving global and regional requirements. You will act as a trusted regulatory advisor to project teams, clients, and affiliates, ensuring regulatory activities are executed efficiently and strategically across the MENA region.Key Responsibilities

Develop and implement regulatory strategies to support new submissions and lifecycle management activities, ensuring ongoing compliance with global and regional requirements.
Provide strategic regulatory guidance to cross-functional project teams and ensure availability and maintenance of current regulatory documentation
Lead and oversee regulatory operational activities to ensure timely, high-quality submission delivery
Manage the communication, development, and execution of MENA regulatory strategies for Safety Update submissions and LCM activities
Take accountability for the execution of lifecycle management submission packages across all MENA markets.
Collaborate closely with affiliates, business partners, artwork teams, pharmacovigilance, and other cross-functional stakeholders to maintain supply continuity and prioritise patient safety.
Lead and participate in regular cross-functional meetings to ensure alignment, transparency, and effective information exchange.
Ensure labelling submissions are delivered in line with CDS-compliant timelines
Contribute to continuous improvement initiatives and process enhancements as requiredWhat you'll need to succeed

Senior regulatory professional with strong experience managing regulatory strategies and submissions across MENA markets
Proven ability to lead complex lifecycle management and safety-related regulatory activities
Strong stakeholder management skills, with experience working across affiliates, partners, and cross-functional global teams
Strategic mindset combined with hands-on execution capability
Excellent communication skills and the confidence to act as a regulatory subject-matter expertWhat you'll get in return
Remote working, outside IR35
What you need to do now

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