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Regulatory Affairs Process Strategist
vor 2 Wochen
Job Description Summary
We are seeking a talented Regulatory Affairs Process Strategist to join our team at the Healthcare Businesswomen's Association. As a key member of our regulatory operations team, you will be responsible for developing and implementing effective processes that drive compliance and excellence in our regulatory affairs function.
About the Role:
- Develop and implement process improvements that enhance efficiency, reduce risk, and drive compliance
- Collaborate with cross-functional teams to ensure seamless integration of regulatory processes into our business operations
- Analyze emerging regulations and guidelines to identify impact on our processes and develop strategies to mitigate risks
- Contribute to inspection and audit readiness by ensuring accurate and complete documentation of our processes and procedures
- Provide subject matter expertise in process design, risk management, governance, and compliance to support organizational goals
Requirements:
- Bachelor's degree in Life Sciences or related field
- Minimum 5 years of experience in regulatory affairs, with a focus on process development and implementation
- Strong knowledge of regulatory requirements and industry standards, including GxP and QMS
- Excellent analytical, communication, and project management skills
- Able to work effectively in a matrix environment and collaborate with diverse stakeholders
