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Regulatory Affairs Senior Manager

  1. London
  1. Contract
  1. Life Sciences
Date Posted16 Sep 2019
Are you looking for your next Regulatory Affairs Senior Manager position?  Are you looking to expand and grow within a fabulous team?  Then please read on and apply.

We are looking for a highly skilled professional to join our client on a 12 month contract.  Some of the duites and responsiblities will include the following:
  • Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs) 
  • Communicates regulatory strategies as appropriate such that expectations are understood. 
  • Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management 
  • Develop predictions for expectations and risks associated with outcomes by regulatory agencies 
  • Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments) 
  • Collaboration 
  • Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations 
  • Communicate and ensure alignment of regional management before GRT strategy decisions 
  • Partner with regional management and peers to ensure consistency in procedures and agency interactions 
  • Regulatory Research 
  • Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to our clients products. 
  • Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. 
  • Evaluates and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labeling 
  • Health Authority Interactions 
  • Act as contact and create relationships with agency staff on specific product assignment 
  • Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management 
  • Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy—includes contingency regulatory planning/risk assessment 
We are looking for an all-rounder, who is flexible and willing to work across multiple areas, including but not limited to: - pediatric plans - drugs in development - variations - new line extensions - post marketing The candidate MUST be personable and have AT LEAST 10 years experience. Please only submit candidates who have experience that includes: - strategic management - providing key scientific advice to team - EU centralised focus - EU legislation and guidelines - up to date to current key regulatory topics.

Excellent rates apply.

Please contact Kathryn Taylor for futher information.

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