Regulatory Medical Writer - Pharmaceuticals

Smart4Sciences; Derby; On-site; GBP 40,000 - 60,000; Full time

Job summary

A pharmaceutical consultancy is seeking an experienced Regulatory Medical Writer to support Marketing Authorisation Applications (MAAs) for generic products. The role involves preparing clinical summaries, ensuring regulatory compliance, and collaborating with experts. Ideal candidates should have a relevant degree and prior experience in regulatory writing. This is a great opportunity for career development in an innovative environment.

Qualifications

• Advanced degree in a relevant field is preferred.
• Experience in regulatory medical writing is essential.
• Must have a strong understanding of EMA, FDA, ICH, and GCP guidelines.

Responsibilities

• Prepare clinical and non-clinical overviews for MAAs.
• Support product variations and clinical updates.
• Ensure compliance with regulatory guidelines.

Skills

Regulatory Medical Writing

Bioequivalence Knowledge

Communication Skills

Education

Degree in Life Sciences, Pharmacy, or Medicine

Job description

Overview

Regulatory Medical Writer - Pharma Consultancy

Are you an experienced Regulatory Medical Writer looking to join a growing consultancy that partners with leading pharmaceutical and medical device companies worldwide? This is an exciting opportunity to play a key role in supporting Marketing Authorisation Applications (MAAs), predominantly for generic pharmaceutical products.

Responsibilities

• Prepare clinical and non-clinical overviews and summaries from literature and bioequivalence data
• Support product variations, renewals, and clinical updates
• Collate supporting bibliographies for CTD dossiers (Modules 4 and 5)
• Interpret and summarise complex scientific data with accuracy and clarity
• Ensure compliance with EMA, FDA, ICH and GCP guidelines
• Partner with subject matter experts and clients to align regulatory strategy and documentation
• Manage timelines, revisions, and version control across multiple projects

Qualifications

• A degree in Life Sciences, Pharmacy, Medicine, or related discipline (advanced degree preferred)
• Prior regulatory medical writing experience
• Strong knowledge of bioequivalence, biowaivers, and bridging studies
• Proven track record in authoring Modules 2.4 & 2.5, plus bibliographic collation
• Excellent communication skills and client-facing confidence
• Ability to balance scientific rigour with pragmatic, solution-driven thinking

This is a fantastic opportunity to develop your career in regulatory writing within a consultancy that values innovation, expertise, and people.

Apply today or reach out to Gareth Gooley on to find out more