Senior Associate Regulatory Affairs CMC - JP30501

3 days left

England, London, Uxbridge
22 Feb 2021
08 Mar 2021
Guy Shipman
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Senior Associate Regulatory Affairs CMC - JP30501

12 month contract

£26.86 per hour pay

Work From Home until COVID restrictions end - preference to then be based in Uxbridge

Global Biopharmaceutical company

2 round interview process

Reasoning for hiring - increase workload, increased number of products team needs to support with

Overview of role

- CMC submissions globally, compiling submissions for all countries for clinical trials and marketing applications.

- Lots of work with strict timelines, working well stakeholders and timeline pressures

Job Description

The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle.

Support may include organizing, managing and executing on regulatory CMC projects and submissions. Tasks may include creating and/or maintaining submission timelines and tables of contents, formatting of documents per style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested.

Candidate MUST haves:

- Strong written and communication skills
- Degree in life sciences, biochemistry, or chemistry
- Candidates need to be able to demonstrate a proactive nature
Manager is open to graduates with limited experience, the IDEAL candidate would have 1 year regulatory experience in a similar role

Ideal candidate also has;

  • proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
    * strong organizational skills with attention to detail;
    * excellent time management skills and ability prioritize workload;
    * project management skills;
    * adept interpersonal and communication skills (both verbal and written);
    * ability to work both independently and as a member of a team.

    Preferred Qualifications

Degree in life sciences, biochemistry, or chemistry
Experience in biopharmaceutical or pharmaceutical industry
Familiarity with eCTD structure
Motivated with initiative to learn quickly
Experience in CMC, including preparation of submissions to Agencies

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