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Senior Associate Regulatory Affairs CMC - JP30501

Employer
i-Pharm Consulting
Location
England, London, Uxbridge
Salary
Negotiable
Start date
22 Feb 2021
Closing date
8 Mar 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

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

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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