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- Tasks: Lead and produce high-quality regulatory documents for global health authorities.
- Company: Join Omnicom Health Regulatory, a leader in regulatory writing and scientific services.
- Benefits: Competitive salary, career growth, and a supportive team environment.
- Why this job: Make a real impact in the pharmaceutical industry while developing your expertise.
- Qualifications: Experience in regulatory writing and strong mentoring skills required.
- Other info: Opportunity to specialise and expand knowledge across various therapeutic areas.
The predicted salary is between 36000 - 60000 £ per year.
Omnicom Health Regulatory is a global, market-leading regulatory writing and scientific services group within the Omnicom Health network. 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.
We are seeking an experienced Associate Director, Regulatory Writing to join our growing team. You will play a key role in writing and reviewing a broad range of regulatory documents, with a particular focus on strategic, high-level submissions and materials for global health authorities.
- Mentor and coach less experienced Regulatory Writers and contribute to the training of new Regulatory Writers.
- Work with relevant line manager to understand the capabilities and training plans for writers when coaching.
- Demonstrate robust commercial/financial awareness of project budgets and scopes of work.
- Participate in business development by assisting in developing relationships with new clients.
- 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.
- 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.
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.
Associate Director of Regulatory Writing in England employer: Complete Regulatory | An IPG Health Company
Contact Detail:
Complete Regulatory | An IPG Health Company Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director of Regulatory Writing in England
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory writing field on LinkedIn or at industry events. We can leverage our connections to get insights and maybe even referrals that could land us an interview.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and recent developments in the pharmaceutical industry. We should be ready to discuss how our experience aligns with the needs of the role, especially around high-level submissions.
✨Tip Number 3
Showcase our expertise! Bring samples of our previous work to interviews, especially those that highlight our ability to produce high-quality regulatory documents. This will demonstrate our skills and give potential employers a taste of what we can bring to their team.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email reiterating our interest in the position and highlighting key points from the conversation can keep us top of mind. Plus, it shows our professionalism and enthusiasm for the role.
We think you need these skills to ace Associate Director of Regulatory Writing in England
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Associate Director role. Highlight your experience in regulatory writing and any specific projects that align with what we do at Omnicom Health Regulatory.
Showcase Your Skills: Don’t just list your skills—demonstrate them! Use examples from your past work to show how you’ve successfully led projects, mentored others, or navigated complex regulatory requirements.
Be Clear and Concise: Regulatory writing is all about clarity. Make sure your application is well-structured and easy to read. Avoid jargon unless it’s necessary, and keep your sentences straightforward.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity within our talented team!
How to prepare for a job interview at Complete Regulatory | An IPG Health Company
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory guidelines and standards relevant to the role. Familiarise yourself with the types of documents you'll be working on, like clinical study protocols and regulatory submissions. This will show that you're not just a good writer, but also someone who understands the regulatory landscape.
✨Showcase Your Leadership Skills
As an Associate Director, you'll be mentoring less experienced writers. Be prepared to discuss your coaching style and any past experiences where you've successfully led a team or project. Highlight how you can contribute to the training of new writers and foster a collaborative environment.
✨Demonstrate Commercial Awareness
Understand the financial aspects of regulatory writing, including project budgets and scopes of work. Be ready to discuss how you've managed workloads and timelines in previous roles, and how you can apply that experience to help the company grow and maintain client relationships.
✨Prepare for Scenario Questions
Expect to face scenario-based questions that assess your problem-solving skills and ability to handle conflicting timelines. Think of examples from your past where you've navigated challenges in regulatory writing or project management, and be ready to explain your thought process and outcomes.