Senior International Consultant - Regulatory Affairs and Executive search
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, permanent position, working remotely.
Applicants must have the full Right to Work in the UK, as our client is unable to sponsor.
We are an equal opportunities employer and welcome applications from all qualified candidates.
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