Regulatory Affairs Associate

Location
London, Uxbridge, England
Salary
Negotiable
Posted
02 Jun 2021
Closes
16 Jun 2021
Ref
REGASSOCMC
Contact
Guy Shipman
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Entry level

Regulatory Affairs Associate (CMC)

12 month initial contract - 24 months guaranteed

Uxbridge site

Competitive hourly pay rate

Global biopharmaceutical company

37.5 hour week commitment

APPLICANTS MUST BE BASED IN THE UK AND HAVE THE RIGHT TO WORK IN THE UK UPON APPLICATION

Description

The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development.

Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions.

Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested.

What we are looking for:


  • Desire to learn Regulatory Affairs CMC and global submission strategy;
    * Strong organizational skills with attention to detail;
    * Proficient time management skills and ability prioritize workload;
    * Ability to work both independently and as a member of a team;
    * Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
    * Qualified to work in the UK without employer sponsorship;
  • Experience


o Bachelor's or Master's degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience

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