Company Overview

Our client is an established pharmaceutical company with a strong and growing presence in the UAE and across the wider MENA region. With a portfolio spanning new products, line extensions and lifecycle management, the business is investing in its regulatory capability to support the next phase of growth.

This is a senior leadership hire into a business that values ambition, ethics and teamwork, and gives its leaders genuine ownership of their function.

The Role

The Head of Regulatory Affairs will lead the regulatory function and report directly to the Chief Operations Officer. You will set and deliver the regulatory strategy that gets products approved on time and keeps them compliant throughout their lifecycle.

Acting as the company’s primary point of contact with regulatory authorities, you will shape how the business navigates a complex and changing regulatory landscape, working closely with Market Access, Public Affairs and cross-functional teams. You will also lead and develop the regulatory team, building a culture of quality, accountability and continuous improvement.

Key Responsibilities

Regulatory Strategy

• Develop and execute regulatory strategies to support the timely approval of new products, line extensions and variations

• Work with cross-functional teams to build regulatory requirements into product development plans and timelines

• Monitor regulatory changes, assess the impact on the business and give proactive guidance to stakeholders

• Oversee risk assessments and risk minimisation strategies, and monitor safety data to support the safety profile of the portfolio

Authorities and Stakeholders

• Serve as the primary point of contact with regulatory agencies, ensuring timely and accurate submissions

• Build strong relationships with regulatory authorities, industry associations, healthcare professionals and external partners

• Ensure effective management of safety issues, regulatory compliance and transparent adverse event reporting

• Communicate regulatory requirements clearly to internal teams, including R&D, manufacturing, marketing and legal

Quality and Compliance

• Ensure compliance with regulatory requirements and guidelines across clinical development, manufacturing and post-marketing activities

• Lead regulatory inspections and audits, coordinating responses and implementing corrective actions

• Champion a proactive culture of quality and compliance across the organisation

Leadership and People

• Lead, mentor and develop the regulatory affairs team, setting clear expectations and empowering ownership

• Support the professional growth of junior team members

• Stay ahead of industry trends and best practice, sharing insight across the team and wider business

Qualifications

• Bachelor’s degree in Pharmacy

• 10 to 15 years of experience in Regulatory Affairs within the pharmaceutical industry

• Solid experience in Market Access and Public Affairs in the UAE

• Experience across the wider MENA region is a strong advantage

• Proven leadership experience, with the ability to build and develop a high-performing team

• Strong analytical, problem-solving and decision-making skills

• Excellent communication and interpersonal skills, with confidence engaging senior stakeholders and authorities

• A creative and innovative approach to regulatory strategy

The Offer

• A senior leadership role reporting directly to the Chief Operations Officer

• Full ownership of the regulatory function and the chance to shape its direction

• High visibility across the business and with regulatory authorities in the UAE and MENA

• A competitive salary and benefits package

Apply below to discuss further.