• ALL ACCOUNTABILITIES (as applicable) WILL BE CARRIED OUT IN COMPLIANCE WITH cGMP STANDARDS

• Utilize scientific and regulatory knowledge to develop and manage all regulatory information related to ingredients, formulations, religious compliance, organic and label compliance to corporate and government regulations ensuring regulatory compliance in the markets where the organization has a business interest

• Meet customer expectations in documentation turnaround time and accuracy

• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures

• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents

• Recommend changes to company procedures in response to change in regulations or standards

• Perform and maintain a regulatory risk assessment and provide timely recommendations and projects in response to emerging issues related to the company

• Maintain Vendor Approval and New Products Program

• Maintain documentation for the Stability Program

• Assist with internal audits and the corrective action follow up

• Assist with supplier audits and the corrective action follow up

• Investigate customer complaints and ensure corrective actions are completed

• Perform Investigation, Root Cause Analysis, and CAPA for Incident and Loss Program and non-conforming materials

• Maintain Management of Change Program

• Perform other related and assigned duties by senior management

Education

• Minimum – 4 year University Degree

Experience

• 3+ years work experience

Specific skills

• Working knowledge and experience pertaining to regulatory requirements in an FDA regulated environment

• Strong analytical experience ..... With the ability to learn new technologies quickly

• Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment

• Ability to assess situations and develop solutions

• Effective communications and report writing skills; legible handwriting required

• Strong leadership skills

• Results driven, strong work ethic

• Strong organizational and time management skills

• Must possess a valid US driver’s license