- Communicate with government agencies (such as USDA and FDA) and business partners on regulatory matters.
- Provide documentation to distribution partners and international agencies for product registration.
- Support new product licensing procedures.
- Manage permits for the import and export of materials and products.
- Collaborate with departments to organize and monitor clinical trials.
- Develop protocols and final reports for trials.
- Review, update, and draft Standard Operating Procedures (SOPs).
- Devise ASR/Sampling Plans for different materials and products.
- Lead Document Control processes for timely approvals.
- Provide guidance on regulatory requirements to departments.
- Review and update MAO Surveys regularly.
- Streamline processes for evaluating new vendors.
- Maintain a system to track seed and cell records for product lineage.
- Conduct inspections related to MAO issues.
- Stay updated on relevant regulations.
- Provide training for Regulatory staff.
- Manage new product development and support Quality Assurance.
- Perform other assigned duties as required.
- Bachelor's degree in biological sciences required; Master's degree preferred.
- Experience in new business development, statistical analysis, and clinical trials advantageous.
- Proficiency with Microsoft Office Suite and electronic document control systems.
- Hiring diverse talent.
- Maintaining an inclusive environment through self-reflection.
- Building a culture of care, engagement, and recognition.
- Ensuring growth opportunities for employees.
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Senior Regulatory Affairs Associate - Des Moines, United States - Actalent
Description
Regulatory Support and Compliance Specialist
Are you passionate about ensuring regulatory compliance for new product development? Join our team as a Regulatory Support and Compliance Specialist to oversee activities in alignment with guidelines from regulatory agencies like USDA, FDA, and international bodies.
Distribute and evaluate Materials of Origin surveys to assess raw materials and vendors for compliance.
Additional Skills & Qualifications:
About Actalent
Actalent is a leading provider of engineering and sciences services. Leveraging a vast network of consultants and clients worldwide, Actalent drives innovation and speed to market for Fortune 500 companies.
Diversity, Equity & Inclusion
The company promotes diversity, equity, and inclusion, embracing individuals from all backgrounds. It is an equal opportunity employer that values all applications regardless of race, sex, age, or other characteristics protected by law. Accommodation requests due to disabilities can be made through the indicated email for alternative options.
