Regulatory Affairs Senior Manager
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)
- 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
Excellent rates apply.
Please contact Kathryn Taylor for further information.
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