Senior Regulatory Writer

Senior Regulatory Writer

Maidstone Full-Time 43200 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Write and review regulatory documents for global health authorities.
  • Company: Join IPG Health Medical Communications, a leader in medical communications with over 800 experts worldwide.
  • Benefits: Enjoy flexible time off, private healthcare, and hybrid working options.
  • Why this job: Be part of a high-performing team making a real impact in the pharmaceutical industry.
  • Qualifications: A degree in life sciences and prior regulatory writing experience are preferred.
  • Other info: We celebrate diversity and encourage all backgrounds to apply.

The predicted salary is between 43200 - 72000 £ per year.

Complete Regulatory is part of IPG Health Medical Communications, home to some of the world’s most celebrated and awarded med comms agencies. With over 800 experts globally, IPG Health Medical Communications is dedicated to combining science, creativity, and technology to deliver exceptional medical communications solutions.

What We Do

At Complete Regulatory, we offer industry-leading regulatory writing and consultancy services to pharmaceutical and biotechnology clients. We specialise in delivering high-quality clinical and regulatory documentation across a wide range of therapy areas, including:

  • Clinical Study Reports (CSRs)
  • Protocols and Amendments
  • Clinical Summaries and Overviews (e.g., CTD Modules 2.5 and 2.7)
  • Regulatory responses and briefing documents
  • Other essential documentation for global submissions

The Role: Senior Regulatory Writer

We are seeking experienced Senior Regulatory Writers to join our growing team. You’ll play a key role in writing and reviewing a broad range of regulatory documents, with a particular focus on strategic, high-level submissions for global health authorities.

Key Responsibilities

  • Develop and deliver high-quality regulatory documents in line with guidelines
  • Lead the creation of complex documentation such as clinical overviews, summaries, and briefing packages
  • Provide strategic consultancy to clients, demonstrating critical thinking and a deep understanding of regulatory requirements
  • Maintain and enhance strong client relationships through effective communication and expert guidance
  • Support and mentor junior writers, contributing to the development of internal expertise

What You’ll Bring

  • A degree in a life sciences discipline (PhD or equivalent research experience is advantageous but not essential)
  • Prior regulatory writing experience in the pharmaceutical industry, medical communications agency or CRO
  • Strong understanding of global regulatory requirements and submission standards
  • Excellent scientific writing, project management, and interpersonal skills
  • A collaborative, flexible mindset and a drive for high-quality output

What You’ll Get in Return

This role offers an excellent opportunity to advance your career within a highly specialised and supportive team, while benefiting from the reach and resources of the wider IPG Health network.

You’ll also receive a competitive package, including:

  • Flexible Time Off – uncapped paid leave
  • Private healthcare and life assurance
  • Pension scheme
  • Employee Assistance Programme
  • Headspace and MYNDUP – mental health and wellbeing resources
  • Retail and gym discounts
  • Training and professional development
  • Cycle to work scheme
  • Long Service Award
  • Season ticket loan
  • Flexible and hybrid working options

If you\’re looking for your next challenge in regulatory writing and want to be part of a high-performing, expert-led team, we’d love to hear from you.

To Apply or Contact Us

Apply by clicking the link below.

IPG Health Medical Communications is home to the world’s most celebrated and awarded med comms agencies, united by a healthy obsession with creating exceptional medical communications for our clients. Our people are the beating heart of our organisation, and through the positive culture we champion, our teams create communications that not only have a positive impact for our clients, but also impact on the world around us.

We celebrate diversity and encourage applicants from all whatever their background and/or disability. We want you to have every opportunity to shine and show us your talents, so please reach out and let us know if there are any reasonable adjustments we can make to ensure our assessment process works for you.

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Contact Detail:

Complete Regulatory | An IPG Health Company Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior Regulatory Writer

✨Tip Number 1

Familiarise yourself with the latest global regulatory guidelines and submission standards. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.

✨Tip Number 2

Network with professionals in the regulatory writing field, especially those who work at IPG Health or similar organisations. Engaging with them on platforms like LinkedIn can provide insights into the company culture and expectations.

✨Tip Number 3

Prepare to discuss specific examples of your previous regulatory writing projects during interviews. Highlight your strategic thinking and how you navigated complex documentation challenges to meet client needs.

✨Tip Number 4

Showcase your mentoring experience if applicable. Discuss how you've supported junior writers in the past, as this aligns with the role's responsibilities and demonstrates your leadership potential.

We think you need these skills to ace Senior Regulatory Writer

Regulatory Writing
Clinical Study Reports (CSRs)
Protocol Development
Clinical Summaries and Overviews
Regulatory Submissions
Strategic Consultancy
Critical Thinking
Client Relationship Management
Scientific Writing
Project Management
Interpersonal Skills
Attention to Detail
Understanding of Global Regulatory Requirements
Mentoring and Coaching

Some tips for your application 🫡

Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Regulatory Writer position. Tailor your application to highlight relevant experience in regulatory writing and your understanding of global submission standards.

Craft a Strong CV: Your CV should clearly outline your educational background, relevant work experience, and specific skills related to regulatory writing. Emphasise any previous roles where you developed high-quality regulatory documents or provided strategic consultancy.

Write a Compelling Cover Letter: In your cover letter, express your passion for regulatory writing and how your skills align with the company's mission. Mention your ability to mentor junior writers and your commitment to maintaining strong client relationships.

Proofread Your Application: Before submitting, thoroughly proofread your CV and cover letter for any grammatical errors or typos. A polished application reflects your attention to detail, which is crucial in regulatory writing.

How to prepare for a job interview at Complete Regulatory | An IPG Health Company

✨Showcase Your Regulatory Knowledge

Make sure to brush up on global regulatory requirements and submission standards. Be prepared to discuss specific examples from your past experience that demonstrate your understanding of these guidelines.

✨Demonstrate Your Writing Skills

Bring samples of your previous regulatory documents, such as Clinical Study Reports or Protocols. This will not only showcase your writing ability but also give you a chance to discuss your thought process behind each document.

✨Prepare for Strategic Discussions

Since the role involves providing strategic consultancy, think about how you can contribute to high-level submissions. Prepare to discuss scenarios where you've had to think critically and provide expert guidance to clients.

✨Emphasise Team Collaboration

Highlight your experience in mentoring junior writers and working collaboratively within a team. Discuss how you’ve contributed to developing internal expertise and maintaining strong client relationships through effective communication.

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