Associate Director, 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.

Key Responsibilities

• Mentor and coach less experienced Regulatory Writers and contribute to the training of new Regulatory Writers.
• Contribute to sharing existing expertise and acting as a role model; work with relevant line manager to understand the capabilities and training plans for writers when coaching.
• Work with and support other team members to ensure strong teamwork and consistency/best practice.
• Build positive relationships with clients by providing a knowledgeable point of contact; contribute to discussions to identify issues and recommend solutions, effectively agreeing schedules and resolution of issues.
• Confidently lead and facilitate client meetings.
• Demonstrate robust commercial/financial awareness of project budgets and scopes of work; work with senior team members to identify issues and support good recoverability.
• Participate in business development by assisting in developing relationships with new clients.

What you’ll bring

• Ability to lead and produce a wide range of high-quality regulatory documentation.
• Lead all types of projects, providing guidance to team members on client and project issues.
• Rapidly assimilate clinical development data and critically evaluate source information.
• Demonstrate a good understanding of the needs of regulatory authorities and client guidelines and use this to provide advice internally and to clients for all types of regulatory documents.
• Brief other team members to support all types of documents, including time allocations, and document requirements.
• Review project work by assessing how well the documentation meets client and regulatory requirements and the appropriateness of material, in terms of readability, accuracy and ‘fit for purpose’.
• Manage workload and conflicting timelines effectively and proactively address any potential challenges with new or existing projects.

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. Alongside this you’ll have a competitive salary package, and the opportunity to continue to grow your career within a leading Regulatory Writing team.

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.