Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Senior Regulatory Operations Associate

Company: ProClinical Ltd
Location: Cambridge
Reference: EL.RA.9981
Closing Date: 06 Dec 16
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

The Company:ProClinical is seeking a Senior Regulatory Operations Associate on behalf of the on of the world's largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 employees globally. For more than 35 years, our client has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. This is a contract position, based in Uxbridge or Cambridge. ...

Requirements:

The Company:

ProClinical is seeking a Senior Regulatory Operations Associate on behalf of the on of the world's largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 employees globally. For more than 35 years, our client has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. This is a contract position, based in Uxbridge or Cambridge.

Job Role:

  • The Senior Associate is responsible for facilitating product development and global registration through the efficient preparation, management and tracking of regulatory documentation and systems.

Job Responsibilities include:

  • Work as part of a global Regulatory Operations team, contributing to global filings
  • Lead key submissions for EU, Switzerland and Emerging Markets
  • Compilation and publishing of submission dossiers for Europe and the emerging markets for clinical trials, paediatrics and marketing applications
  • Work closely with submission content providers to advise on submission content, structure, planning and strategy
  • Work with publishing vendors
  • Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations
  • Preparation of submission ready components from source documents according to regional regulatory agency guidance
  • Document management of ongoing submissions, e.g. building dossier structure, sourcing documents
  • Quality control of submission ready components and submission dossiers
  • Preparation , dispatch and tracking of electronic and paper media
  • Maintenance of submission information in Regulatory Registration Tracking system

Qualifications and Experience:

  • Degree or equivalent combination of experience and knowledge
  • Demonstrated regulatory publishing experience within the pharmaceutical industry;
  • Advanced knowledge of MS word and Adobe Acrobat
  • Use of specialist publishing software to prepare submissions - Insight Publisher preferred
  • Use of electronic document management systems
  • Understanding of Regulatory submission require

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Elise Lambeth on +44 207 4400 633 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Senior Regulatory Operations Associate

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.