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Job Details

Regulatory Affairs Officer - UK (North) - Contract

Company: Umbilical Life
Location:
Reference: MATTRAOFF
Closing Date: 20 Nov 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Matt Law at Umbilical Life is recruiting an experienced Regulatory Affairs Officers, on a Contract basis for a growing Pharma in the North of England.

Requirements:

Matt Law at Umbilical Life is recruiting an experienced Regulatory Affairs Officers, on a Contract basis for a growing Pharma in the North of England.

 

Responsibilities:

  • Assists with the preparation of regulatory filings for submission to UK and international health agencies in the areas of new drug development, marketing applications and approved product support.

  • Assists with or executes the electronic publication and submission of documents to the MHRA.

  • Compiles materials required in submissions, license renewal and annual registrations.

  • Monitors and improves tracking/control systems.

  • Participates in Regulatory interaction with internal departments and external customers.

  • Monitors and maintains awareness of the UK and global regulatory environment, assessing impact to regulatory affairs practices and procedures.

  • Prepares or assists in the preparation of routine regulatory reports including NDA and IND annual reports, PADERs, PSURs and DSURs.Participates in the development and review of departmental SOPs.

  • In collaboration with external pharmacovigilance vendor, maintains on-site pharmacovigilance files and records and ensures their completeness and readiness for external (including health authority) audit or inspection.

  • Assists the Chief Medical Officer as needed to ensure appropriate level of Company oversight of pharmacovigilance vendor.

 

Qualificaions and Experience:

  • Bachelor degree in the life sciences, chemistry, pharmacy, or other related course of study from accredited college or university; advanced degree is preferred.

  • Minimum two years of relevant experience in pharmaceutical, biological product, or medical device Regulatory; will consider candidates with experience outside of regulatory affairs but with transferrable skillsets.

  • Excellent written and verbal English communication skills.

  • Ability to manage multiple projects, set priorities and meet deadlines.

  • Keen attention to detail

  • Strong ability in the use of writing and publishing computer applications; sufficient IT comfort to be able to learn new software specific to the regulatory affairs functions.

  • Excellent skills in MS Office: Word, PowerPoint, Excel, Outlook.

 

For a confidential discussion please contact Matt at Umbilical on +44 (0) 116 461 0081 or email matt@umbilical-life.com 

 

 

Apply for this job: Regulatory Affairs Officer - UK (North) - Contract

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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