Overview

Reference Number: JO-2104-465960
Senior/Principal Regulatory Writer
Rate: Negotiable
Job Type: Permanent
Location: Macclesfield

Role: Principal/Senior Regulatory Writer
Location: fully home-based occasional travel to the office
Salary: Competitive + benefits
employment: full time, permanent
Job reference:

CPL Life Sciences are collaborating with an international, independent agency group that offers strategic scientific communications to international pharmaceutical, biotechnology, and medical device companies. Our client is seeking an experienced Senior/Principal Regulatory Writer to join their team. You will lead the planning and delivery of regulatory submissions and other large regulatory projects, preparing clinical regulatory documents in a diverse range of therapy areas for their pharmaceutical clients, and be able to evaluate scientific data objectively.

In terms of experience, our client is looking for candidates with drug-development experience, relevant to the field of regulatory writing.You will need a strong scientific background, including a minimum of a BSc (or equivalent) in an appropriate scientific discipline.You must have excellent written and spoken English skills, and a good working understanding of clinical development and ICH guidelines for regulatory documents.You should have authored a range of regulatory documentation including common technical document (CTD) modules, and regulatory briefing and response documents. Experience in leading regulatory submissions is essential, and experience inline management would be advantageous.

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