Head of Regulatory, Quality & Compliance

Head of Regulatory, Quality & Compliance

The Head of Regulatory, Quality & Compliance will have the following responsibilities:

• Responsible for company Regulatory, Quality and Compliance strategy
• Will lead company wide Quality Assurance and Regulatory Affairs department to facilitate product development and commercialization.
• Will develop the organizational / product regulatory and quality assurance strategies.
• Assures regulatory compliance and quality assurance functions required to develop accurate specifications, service, and deliver of products to customers.
• Manages and modifies a complete and comprehensive quality system to support development and contract manufacturing of animal health products.
• Evaluates and controls vendor reliability of goods and services.
• Manages regulatory elements of development schedules, personnel, resources and continuous improvement efforts to achieve efficient product creation and effective transfer of manufacturing.
• Prepares documentation and submits regulatory filings.
• Conducts on site audits of various business units product and processes and host regulatory agency audits as needed.
• Provides company wide education and guidance in quality / regulatory sciences.
• Serve as primary regulatory representative responsible for facilitating all regulatory agency interactions.
• Provide appropriate communication and guidance to management and other internal functional areas responsible for submitting required regulatory documentation.
• Responsible assisting in development, and preparation for market, new products as outlined on the Company product strategy plan.
• Familiar with market trends and competitors.
• Participate in developing new products and labels, product timelines.
• Be familiar with product labeling requirements and BMP Standards to maintain compliance with regulatory requirements.
• Interface with sales representatives, brokers, consumers, technicians, consultants.
• Responsible for tracking approved product labels.
• Compliance with AAFCO/NASC/FDA labeling requirements.

PERSONAL QUALIFICATIONS:
• BS Degree or higher along with 8 plus years of related work experience with 3-5 years of recent management background.
• Must have implementation of Quality / Regulatory along with animal health product development and manufacturing experience.
• Strong leadership skills and experience.
• Advise the company on the regulatory aspects and climate that would affect proposed activities.
• Must be a self-motivated person who can work with a minimum of supervision.
• Must be able to work across multiple, internal organizations with varying outputs.
• Have the ability to motivate others.
• Maintain excellent communication and relationships with other people to foster real team effort within the Company.
• Must be well organized, able to work with deadlines and under pressure while maintaining a level disposition.
• Must be able to work on multi-level projects with emphasis on timely follow-up.
• Must be team player. Have the ability to delegate, follow-up and maintain a positive attitude.

To be immediately considered for this opportunity, please apply here

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