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- Tasks: Lead and produce high-quality regulatory documents while mentoring a talented team.
- Company: Join Omnicom Health Regulatory, a global leader in regulatory writing and scientific services.
- Benefits: Career growth, supportive environment, and access to a vast network of expertise.
- Why this job: Make a real impact in the pharmaceutical industry by ensuring medicines are approved worldwide.
- Qualifications: Experience in regulatory writing and strong leadership skills required.
- Other info: Dynamic role with opportunities to specialise and expand your 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. 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 as a senior leader within 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 clients 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.
- 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.
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.
Regulatory Writing Director 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 Regulatory Writing Director
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory writing field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Show off your expertise! Prepare a portfolio of your best regulatory documents and be ready to discuss them in detail during interviews. This will demonstrate your skills and give you an edge.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors, focusing on common questions for regulatory writing roles. This will help you articulate your experience and approach confidently.
✨Tip Number 4
Apply through our website! We love seeing candidates who take the initiative. Tailor your application to highlight your leadership and business development skills, and let us know how you can contribute to our team.
We think you need these skills to ace Regulatory Writing Director
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Writing Director role. Highlight your relevant experience in regulatory writing and any leadership roles you've held. We want to see how your skills align with what we do at Omnicom Health Regulatory!
Showcase Your Expertise: Don’t hold back on demonstrating your knowledge of regulatory processes and documentation. Include specific examples of projects you've managed or documents you've produced that showcase your technical writing skills. This is your chance to shine!
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it's relevant to the role. We appreciate clarity, especially in regulatory writing, so show us you can communicate effectively!
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 the role. Plus, it gives you a chance to explore more about our team and what we do!
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 pharmaceutical and biotech industries. Being able to discuss specific regulations and how they impact documentation will show that you’re not just a writer, but a knowledgeable expert in the field.
✨Showcase Your Leadership Skills
As a Regulatory Writing Director, you'll need to lead and mentor others. Prepare examples of how you've successfully managed teams or projects in the past. Highlight your coaching style and how you foster collaboration among team members to achieve project goals.
✨Demonstrate Commercial Acumen
Be ready to discuss how you’ve contributed to business development in previous roles. Share specific instances where your insights led to securing new clients or expanding existing relationships. This will illustrate your understanding of the commercial side of regulatory writing.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle multiple projects with tight deadlines. Think about your prioritisation strategies and be prepared to share examples of how you’ve successfully managed competing demands while maintaining high-quality outputs.