Global Regulatory Manager - 6 months

Key People

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Job ID :

10551


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

regulatory, cta, biologics, small molecules, CTA, clinical trials, EU, Basel, Switzerland, regulator


Salary :

£80 - £120 per hour


Date Posted :

26 Feb, 2018



Company Name :

Key People


Location1 :

Basel




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

My client, a Top 5 Pharmaceutical company based in Switzerland, is currently searching for an experienced Regulatory professional to join their team as a Regulatory Manager on an initial 6 month contract basis.

JOB DESCRIPTION:
-Provide support to the team in planning and tracking meetings and deliverables to support regulatory submissions
-Support regulatory Lead in the preparation and submission of global original Clinical Trial Applications (CTA).
-Independently prepare maintenance regulatory submission packages such as substantial amendments, DSURs, Investigator Brochures, Clinical Study Reports, etc.
-Support the coordination of teams in the preparation of Health Authorities responses to submissions
-Interpret and understand regulatory implication of non-clinical and clinical data. Provide strategic regulatory input into selected clinical trials documents such as protocols, IBs, DSURs.

IDEAL BACKGROUND:
-Excellent project management skills with proven ability to manage several projects and competing priorities.
-Strong interpersonal, communication, negotiation and problem solving skills.

Languages:
Fluency in English (written and spoken)

Technical Experience:
-2 - 4 years regulatory experience including proven experience in:
-Planning and compilation of CTAs with special focus on European submissions, including addressing Health Authorities questions.
-Experience with small molecules and biologicals and the review/approval process in Asia is an additional asset.
-Regulatory operational expertise
-Working in a global/matrix environment or cross-functional teams.

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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