Global Regulatory Process Strategist
hace 23 horas
Job Overview
Empresa Reconocida is a leading company with a strong presence in the pharmaceutical industry. We are seeking a highly skilled Global Regulatory Process Strategist to join our team.
About the Role
The successful candidate will develop, maintain and continuously improve processes for aggregate reporting (DSUR, PSUR, US PADER). They will work as part of an international team across five countries, ensuring that our processes are compliant with regulations and internal standards.
Key Responsibilities
The Global Regulatory Process Strategist will be responsible for:
- Leading the review of emerging worldwide regulations and performing impact assessments;
- Driving process changes required to ensure ongoing compliance to global regulatory requirements;
- Developing and maintaining procedural documents, training materials, and communications;
- Establishing clear processes for tracking regulatory compliance and implementing corrective and preventative actions (CAPAs);
- Collaborating with other process owners to ensure alignment and consistency between processes and maximize efficiency.
Requirements
The ideal candidate will have:
- A strong understanding of aggregate reporting (DSUR, PSUR, US PADER) and process set-up;
- Excellent communication skills and knowledge of how to handle critical negotiations;
- Experience working in a global team environment.
What We Offer
We offer a competitive salary of $120,000 per year, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, and employee recognition scheme.
About Us
Empresa Reconocida is a global leader in the pharmaceutical industry, touching the lives of 769 million people in 2020. We are committed to improving and extending more people's lives through digital and technological transformation.
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