Regulatory Affairs Senior Manager

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 duties and responsibilities 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, paediatric 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 labelling 
• 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: - paediatric 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 further information.

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