Director of Regulatory Writing

Company Overview

Omnicom Health Regulatory is a global, market-leading regulatory writing and scientific services group within the Omnicom Health network. By combining the established legacies of Complete Regulatory, HCG, and ProEd, we have created a new powerhouse in the regulatory field—bringing together deep technical writing expertise with high-level scientific and regulatory consultancy.

Our teams support pharmaceutical and biotech clients across the full clinical development lifecycle, delivering technically rigorous, high-quality regulatory documentation to support the development, submission, and approval of medicines worldwide. We produce a wide range of regulatory documents, including clinical study protocols and reports, investigator’s brochures, regulatory submission documents, response documents, patient narratives, and strategic briefing materials for global health authorities.

As a global offering, Omnicom Health Regulatory works closely with clients, internal partners, and regulators across regions and therapeutic areas. We are known for our scientific accuracy, attention to detail, regulatory insight, and collaborative approach. Our structure allows individuals to develop deep specialism within regulatory writing while also broadening their experience across document types, development phases, and strategic regulatory engagements.

We are seeking an experienced Regulatory Writing Director to join our growing team. You will play a key role being a senior leader with a growing regulatory writing function. You will be an experienced writer with strong commercial acumen, focusing on maintaining, winning and growing new business.

Key Responsibilities

• Lead and produce a wide range of high-quality regulatory documentation, coaching and mentoring other writers.
• Manage multiple projects, taking overall responsibility for successful delivery and instilling accountability in others.
• Provide expert and thorough review, giving clear and constructive feedback in a supportive, respectful, and collaborative manner to support development.
• Demonstrate a good understanding of the needs of regulatory authorities and use this to provide advice internally and to clients.
• Able to quickly get up to speed with new clients’ processes and new therapy areas.
• Act as a key source of expertise for projects, including advising internally on client’s standard operating procedures and processes and liaise with client to provide feedback and suggested improvements.
• Manage workload effectively, and prioritize/reprioritize effectively, to meet deadlines for fast-paced and multiple parallel projects.
• Participate in formal and on-the-job training, complete assigned training to the required standard and within the given timeframes. Provide feedback on training to support program development.

What you’ll bring

• Business Development Skills Maintain and secure profitable ongoing business and expand opportunities on projects. Participate in business development by assisting in developing relationships with new clients. Contribute to, and participate in, new proposal development and pitches where appropriate.
• Leadership Development of others Lead, coach and motivate project teams, providing support and guidance to team members on client and project issues, leading troubleshooting discussions regarding project delivery and establishing clear guidelines and ways of working for more complex projects to ensure consistency and efficiency.
• Commercial acumen Demonstrate robust commercial/financial awareness and awareness of budget and scope for each project and communicate this with team members; work with senior team members to identify issues and support good recoverability.

What You’ll Get in Return

This role offers the opportunity to build your career within a highly specialised, supportive, and talented regulatory team, while benefiting from the scale, global reach, and multidisciplinary expertise of the wider Omnicom Health network. You’ll have the opportunity to specialise within regulatory writing while also expanding your knowledge across strategic submissions, global regulatory pathways, and therapeutic areas—within a truly one-of-a-kind regulatory offering.

Part of the IPG Health network, at Complete Regulatory we are a specialized group of experienced regulatory writers proficient in providing high-quality regulatory writing and project management services. Our expertise covers a wide range of therapy areas across the full spectrum of clinical regulatory writing. The way we work is the difference that we bring: Complete Regulatory writers work together as an agile and responsive extension of your team, bringing flexibility and value when you need it most. We bring genuine passion and a personalized approach to the distinct needs of every client company.