Regulatory Affairs Officer

Key People

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Job ID :

1985


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

United Kingdom,West Sussex,West Sussex,


Key Skills :

Regulatory affairs, officer, regulatory officer, Sussex, clinical, post approval


Salary :

£30000 - £35000 per annum + Bonus and benefits


Date Posted :

04 May, 2016



Company Name :

Key People


Location1 :

West Sussex




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

A excellent opportunity has arisen for a Regulatory affairs officer to join a specialist pharmaceutical company based in West Sussex. Within this role you will be responsible for performing & reviewing regulatory affairs activities, including the maintenance of New Product Registrations and the maintenance of existing Product Registrations world-wide.

Responsibilities:

* Ensure regulatory systems, such as Regulatory Database /trackers are implemented and kept up to date.
* Work with internal & external customers to provide data and accurate regulatory input
* Prepare & review labelling/Packaging text. Promotional reviews
* Regulatory representative on projects meeting timelines and costs of project
* Communicate with regulatory agencies and document communication
* Prepare, Review and sign off change control risk assessments
* All paper and electronic files kept up to date and easily locatable
* Input into team activities e.g. brainstorming, best practices etc.
* Prepare & review assigned SOPs
* Review and approval of CTA/IND submission and maintenance documentation
* Prepare & review new product dossiers and annual updates
* Regulatory Authority commitments, quality and safety reviews
* Preparation & review of general regulatory documentation such as Site Master File, Facilities licenses, TSE report
* Review updates to the regulatory environment and suggest impacts

Qualifications/Experience required

* Relevant life sciences degree
* Minimum of 3-5 years in the pharmaceutical field
* Demonstrated ability to write good quality documents
* Communication skills
* Attention to detail/accuracy
* Project management
* Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets
* Proficient user of Microsoft Office

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

Key People is a recruitment consultancy with a reputation for providing good value that's been built up over 20 years. Clients come to us for three main reasons:

> We achieve results faster
> Our candidates really are a cut above
> We add greater value

We think it's because we're a private company driven by clients, not by shareholders.

For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe and also many around the globe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you'll get the chance to work for some prestigious, blue-chip organisations.


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.

View all Key People Jobs



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