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Job Details

Regulatory Affairs Manager - UK - Contract

Company: Umbilical Life
Location:
Reference: MATTRAMGRMIDS
Closing Date: 23 Nov 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Matt Law at Umbilical Life is excited to be recruiting an experienced Regulatory Affairs Manager, for a leading global Biotechnology company based in the Heart of England.

Requirements:

Matt Law at Umbilical Life is recruiting an experienced Regulatory Affairs Manager, for a leading global Pharmaceutical company based in the Heart of England.

 

Responsibilities:

  • Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the companies portfolio in compliance with global filing plans and local regulatory requirements.
  • Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
  • Provides content guidance for regional regulatory documents and meetings in accordance with global strategy.
  • Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
  • Supports regional label negotiation activities
  • Under general supervision participate in the development, and execution of regional regulatory product strategies
  • Obtains and maintains Clinical Trial Authorizations including Response to Questions
  • Communicates regulatory strategies within team
  • Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
  • Qualifications & Knowledge:
  • Scientific Degree and demonstrated experience in a similar role

Regulatory principles

  • Working with policies, procedures and SOP’s
  • Knowledge of legislation and regulations relating to medicinal products
  • Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.
  • Knowledge of drug development
  • Knowledge of and experience in regional regulatory environment
  • Ability to understand and communicate scientific/clinical information

Regulatory Research:

  • Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to company products.
  • Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. 
  • Under supervision evaluates and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling

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 Manager - UK - 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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