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

Regulatory Senior Manager - UK/IR

Company: ProClinical Ltd
Location: Cambridge
Reference: RA.LK.9997
Closing Date: 07 Dec 16
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

ProClinical has a new vacancy at a pharmaceutical company working in research and development of highly effective and innovative medications. This job vacancy is for a Regulatory Senior Manager to join their team at their Cambridge offices in the UK. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation. ...

Requirements:

ProClinical has a new vacancy at a pharmaceutical company working in research and development of highly effective and innovative medications. This job vacancy is for a Regulatory Senior Manager to join their team at their Cambridge offices in the UK. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation. 

Job Role and Responsibilities:

  • Maintain awareness of the current priorities and regulatory needs of the UK and Ireland IAC.
  • Plan, coordinate and prepare MA Applications for submission via National procedures.
  • Provide advice and prepare local documentation for MA Applications for submission via European procedures.
  • Coordinate and respond to questions from Regulatory Agencies during MA applications, MA renewals and variations.
  • Manage the maintenance of MA's via renewals and variations.
  • Management and submission of all national phase activities following the completion of DCP/MRP procedures.
  • Manage the UK and IE Artworks through the Bard Artwork Management System (BART)
  • Manage the maintenance of SmPC and PIL texts on the local websites (eMC/ Ipha)
  • Keep the local companies informed of changes to the product information to allow them to fulfil their business needs effectively.

Experience:

  • Project managing and leading tasks.
  • Taking a high degree of personal responsibility for decision making and problem solving.
  • Point of contact for both product and non-product specific queries with the local companies (Bard, NPL and MPL) and internally from MRL.
  • Management of the UK and IE priorities and workload
  • Representing the UK and IE function as a regulatory IAC
  • Management of pack changes for the UK and IE
  • Compliance & implementation of processes and involvement in development of new processes for better efficiency for the UK & IE function

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 Latifah Khan on +44 203 8234 367 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: Regulatory Senior Manager - UK/IR

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.