Are you a skilled
Regulatory Medical Writer
looking to make an impact in a fast-growing consultancy environment?
Blackfield Associates are working with a growing consultancy, who due to new clients have a requirement for a Regulatory Medical Writer.
This is your opportunity to join a dynamic team supporting the preparation and submission of Marketing Authorisation Applications for generic pharmaceutical products.
As Regulatory Medical Writer, you will be responsible for:
* Author clinical and non-clinical overviews and summaries using published literature and bioequivalence data.
* Support regulatory submissions including variations, renewals, and clinical updates.
* Compile bibliographies for CTD Modules 4 and 5.
* Interpret complex scientific data and present it clearly and accurately.
* Ensure compliance with global regulatory guidelines (ICH, GCP, FDA, EMA).
* Collaborate with subject matter experts and cross-functional teams.
* Manage timelines, document versions, and feedback cycles.
* Engage with clients to understand their product strategy and regulatory pathway.
To be considered for the role, you will have the following skills and experience:
* Degree in Life Sciences, Pharmacy, Medicine, or related field (Advanced degree preferred).
* 3+ years of experience in regulatory medical writing.
* Strong understanding of bioequivalence, biowaivers, and bridging studies.
* Proven experience with Modules 2.4 and 2.5 and supporting bibliographies.
* Excellent communication skills and attention to detail.
* Proficiency in Microsoft Office and reference management tools (e.g., EndNote).
* Ability to manage multiple projects and meet deadlines.
* A pragmatic, client-focused mindset.
This is a full time, permeant position. Working remotely.
Applicants must have the full Right to Work in the UK, as our client are unable to sponsor.