
High-Volume Regulatory Affairs Specialist
3 days ago
We are seeking an experienced and skilled Regulatory Case Manager to join our team. The successful candidate will be responsible for managing high-volume regulatory applications, overseeing key projects, and ensuring operational excellence in a fast-paced environment.
Key Responsibilities:- Lead and mentor a small team within the Veterinary Sciences department.
- Manage regulatory applications, including variations, new applications, transfers, scientific advice, and SPC harmonization.
- Act as Subject Matter Expert for projects and systems.
- Monitor progress, ensure deadlines, and maintain quality standards.
- Produce reports and performance metrics to track team performance.
- Drive process improvements and uphold compliance standards to ensure regulatory requirements are met.
- Represent the organization at meetings and communicate effectively with stakeholders.
To succeed in this role, you will need:
- At least 2 years of relevant office/administration experience.
- Proven people management and leadership skills to motivate and develop your team.
- Strong planning, organizational, and communication abilities to manage diverse workloads and workflows.
- Experience handling high-volume workloads and maintaining productivity under pressure.
- Confidence using workflow/IT systems and performance reporting tools.
- An analytical mindset and problem-solving skills to identify and resolve issues efficiently.
- A self-starter with the ability to work independently and collaboratively as part of a team.
This is an exciting opportunity for an experienced Regulatory Case Manager to take on a challenging role and contribute to the success of our team. If you are a motivated and organized individual with a passion for regulatory affairs, we encourage you to apply.
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