Senior Regulatory Writer

JR United Kingdom; Hemel Hempstead; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in medical communications is seeking a Senior Regulatory Writer in Hemel Hempstead. The role demands expertise in regulatory writing within the pharmaceutical sector, with responsibilities including the creation of key documents for regulatory authorities, leveraging extensive knowledge of FDA and EMA guidelines.

Benefits

Flexible Time Off – uncapped paid 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

• At least 3 years' experience as a regulatory writer.
• Life-science graduates ideally with a PhD or equivalent.

Responsibilities

• Write a wide range of regulatory documents including clinical overviews and summaries.
• Maintain client relationships and provide strategic consulting.

Skills

Knowledge of FDA guidelines

Knowledge of EMA guidelines

Knowledge of ICH guidelines

Regulatory writing

Education

Life-science degree

PhD or research experience

Job description

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Senior Regulatory Writer, hemel hempstead

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Client:

IPG Health Medical Communications

Location:

hemel hempstead, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

10

Posted:

06.06.2025

Expiry Date:

21.07.2025

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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. We are 800 experts obsessed with combining science, creativity, and technology to create exceptional medical communications solutions for our clients.

What do we do?

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 at least 3 years' 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.