Regulatory Affairs Leadership Role
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The ideal candidate will have a deep understanding of the regulatory landscape and be able to provide strategic direction to our team.
We are looking for a highly experienced professional who can lead our regulatory affairs function and ensure compliance with all relevant regulations.
Key Responsibilities:
* Develop and implement regulatory strategies to support business objectives
* Provide expert guidance on regulatory requirements and best practices
* Lead cross-functional teams to resolve complex project issues
* Maintain knowledge of regulatory environment, regulations and guidance's
* Represent Regulatory Affairs at core teams
* Manage preparation and communicate regulatory risk assessment to core team, business unit team and senior management; propose mitigation approaches
* Ensure RA activities are aligned Project timelines & business objectives and are in compliance with ICH, FDA, HC, UK, and EU regulations
* Interact with company partners and consultants for various regulatory matters as needed
* Contribute regulatory perspective as needed on government proposals and external due diligence activities
* Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs