Senior Regulatory Affairs Associate, CMC - 12 month contract

Key People

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Job ID :

6933


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,London,London,


Key Skills :

regulatory affairs, cmc, contract, chemistry, manufacture, control, london, contractor, post approva


Salary :

£25 - £30 per hour


Date Posted :

25 Apr, 2017



Company Name :

Key People


Location1 :

London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

An excellent opportunity has arisen within the CMC team of a leading Biotech company based in London on a 12 month contract basis. You will ideally have between 1-3 years of CMC Regulatory experience and a strong knowledge of Regulatory Affairs.

Responsibilities:

-The Regulatory Professional will contribute in implementation of regional strategies by leading the execution of the preparation of CMC components of filings for one or more products according to the CMC timelines under the direction of the regional lead.
-Responsible for organization and preparation CMC documents for filings from marketing authorisation to post-approval supplements, renewals and responses to questions across all regions.
-Participate in the gathering, consolidating and analysing regulatory intelligence for all regions and support its application to product-specific activities by maintaining templates for regional requirements.
-Responsible for documenting CMC submissions and archiving documents in document management systems.
-Responsible for refining/creating select CMC procedures and systems and will be responsible for interface with regulatory operations staff.
-Authoring of redactions for use in emerging markets for all application types.
-Coordinate reviews and QC of regulatory documentation (e.g. redaction)

Experience Required:

-Broad experience of pharmaceutical/biotechnology or medical device industry
-Specialist knowledge of Regulatory Affairs for a minimum of 1-2 years.
-Strong communication skills - oral and written organizational skills
-Understanding of drug development process
-CMC- specific regulatory knowledge & experience
-Strong interpersonal skills
-Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
-Strong computer skills, including word processing, database document repository and project management software
-Strong team player with a commitment to customer service

Basic Qualifications:

-Bachelor's degree and 1-2 years Regulatory CMC experience

For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to 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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