Job Posted: 11 Jan 2017

Regulatory Affairs Officer

30k - 35k pa + Bonus and benefits| West Sussex| Permanent

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 [Phone number removed] or email a copy of your CV to [Email address removed]

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.