Senior Regulatory Writer

JR United Kingdom; Sheffield; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading medical communications agency is seeking a Senior Regulatory Writer in Sheffield. This role involves producing high-quality clinical documentation and consulting with clients while providing support to the regulatory writing team. Successful candidates will enjoy flexible time off, discounts, and numerous development opportunities.

Benefits

Flexible Time Off

Retail and gym discounts

Great training and development

Employee assistance programme

Private healthcare

Mental health wellness programme

Cycle to work scheme

Season Ticket Loan

Flexible working

Qualifications

• Previous experience as a regulatory writer in the pharmaceutical industry or medical writing agency.
• Life-science graduate, ideally with a PhD or related research experience.
• Thorough knowledge of FDA, EMA, and ICH guidelines.

Responsibilities

• Write a wide range of regulatory documents including clinical overviews and regulatory responses.
• Maintain client relationships, consulting and ensuring effective writing.
• Provide coaching and insight to less experienced team members.

Skills

Regulatory writing

Strategic thinking

FDA guidelines

EMA guidelines

ICH guidelines

Education

PhD or life-science degree

Job description

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Senior Regulatory Writer, sheffield, south yorkshire

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Client:

Complete Regulatory | An IPG Health Company

Location:

sheffield, south yorkshire, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

5

Posted:

31.05.2025

Expiry Date:

15.07.2025

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Job Description:

Who are we?

Complete Regulatory is part of IPG Health Medical Communications, who is home to the world’s most celebrated and awarded Med Comms agencies. IPG Health Medical Communications comprises 800 experts obsessed with combining science, creativity, and technology to create exceptional medical communications solutions for our clients.

What do we do?

At Complete Regulatory, we provide class-leading writing support and consultancy services to the pharmaceutical industry, producing a wide range of high-quality clinical documentation, including clinical study reports, protocols, clinical summaries, clinical overviews, regulatory responses and other supporting documents, across a variety of therapy areas.

The role

We are looking to recruit Senior Regulatory Writers with previous experience as a regulatory writer within the pharmaceutical industry and/or a medical writing agency. Applicants should be life-science graduates, ideally with a PhD or other research experience, although this is not mandatory.

You will use your thorough knowledge of FDA, EMA and ICH guidelines to write a wide range of regulatory documents; these will include strategic requirements, such as clinical overviews, higher-level summaries and briefing documents. You will also help to maintain our excellent client relationships, which will allow you to consult with the client and demonstrate your high-level strategic thinking, based on extensive past experience, to ensure effective medical writing for regulatory authorities.

You will be a highly valued member of the Regulatory Writing team and will have the opportunity to advance your skills while helping less experienced team members to achieve their potential, by providing coaching and insight.

What will you get in return?

This position will benefit anyone looking to build on their experience in regulatory writing, while working within a highly specialised, supportive and reputable team. In addition, you will become part of a larger organisation, which offers a range of world-class services and a flexible organisational structure.

As well as a fresh challenge in your career, long term career choices and development, you will be rewarded with:

· Flexible Time Off – uncapped paid time off

· Retail and gym discounts

· Great training and development

· Employee assistance programme

· Private healthcare

· Headspace and MYNDUP - a mental health wellness programme

· Cycle to work scheme

· Season Ticket Loan

· Flexible working

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.