Regulatory Affairs Director: Global Quality Standards
3 weeks ago
Job Summary:
EPM Scientific is seeking a highly skilled Regulatory Affairs Director to lead our efforts in maintaining and enforcing Global Quality Standards. As a key member of our team, you will oversee investigations, complete Field Alert forms, and manage product recalls. Your primary responsibility will be to ensure compliance with regulatory requirements and support the growth of our organization.
Key Responsibilities:
- Develop and maintain strong relationships with regulatory agencies, including the FDA, to ensure timely resolutions and compliance with Good Manufacturing Practices (GMPs).
- Lead and manage the recall workforce, including staffing requisitions, assigning work, and monitoring performance.
- Prepare and maintain FAR status reports, Field Alert forms, and other regulatory documents as required.
- Oversee the internal processing of Field Alerts, support investigations, and maintain metrics and progress spreadsheets.
- Compile and analyze data on field alerts and recalls, providing insights and recommendations to management.
Requirements:
Education:
- Bachelor's Degree in a science-related field, such as Chemistry, Biology, or Pharmaceutical Science.
Experience:
- A minimum of 5 years of progressive responsibility in maintaining and enforcing GMPs and Regulatory Compliance, with leadership experience.
- At least 3 years of management experience overseeing people, projects, or functional areas.
- Minimum 2 years of thorough knowledge of FDA current Good Manufacturing Practices (cGMPs) and Part 820 requirements.
Salary: $120,000 - $150,000 per year, depending on experience.
Benefits: Comprehensive benefits package, including medical, dental, and vision insurance, 401(k) plan, and paid time off.
Location: Remote work options are available, but occasional travel to our office may be required.
Why Join EPM Scientific:
We offer a dynamic and supportive work environment, with opportunities for growth and professional development. Our team is passionate about delivering high-quality services and making a positive impact in the industry.
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