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Regulatory affairs manager • plano tx
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Regulatory Affairs Manager
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Aloe Vera of America, Inc.Richardson, TX, US- serp_jobs.job_card.full_time
Job Description
Job Description
GENERAL DESCRIPTION : Manage the creation, preparation and achievement of regulatory submissions and approvals in our global markets. Ensure corporate compliance with all regulatory and governmental agency licensing and regulations.
ESSENTIAL DUTIES / RESPONSIBILITIES / FUNCTIONS :
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Plan, coordinate, and prepare document packages for regulatory submissions.
- Submit U.S. and international regulatory applications.
- Maintain submission correspondence files and other regulatory files in a complete and secure manner.
- Provide project, department, and company guidance on current and emerging regulatory affairs requirements, regulations, and processes, and focus on improved regulatory efficiency and effectiveness.
- Ensure that the company is in compliance with all domestic and international regulatory agencies such as The Food and Drug Administration (FDA); Texas Department of Health (TDSHS); REACH; KOSHER; HALAL; IASC; and all foreign country regulatory authorities.
- Schedule Kosher, IASC and Halal inspections and escort the Kosher, IASC and Halal officials during the inspection.
- Respond to regulatory and technical questions from international Office Managers, distributors, and consumers.
- Ensure compliance of cGMPs, environmental regulations, and health and safety regulations.
- Develop and approve Company SOPs for the Department.
- Comply with Company SOPs and policies.
- Act as Regulatory lead on manufacturing and development teams, providing Regulatory Affairs feedback and guidance on regulatory inputs needed for global submission requirements.
- Work with Quality Management to develop and maintain regulatory information for Supplier Database.
- Work with R&D department on regulatory needs for global markets based on proposed product ingredients and formulas.
- Assist with development and maintenance of spreadsheets and tracking tools for measuring department objectives.
- Maintain a professional expertise of regulations through regulatory literature, courses, and seminars.
- Additional duties may be assigned as needed.
SUPERVISORY RESPONSIBILITIES :
QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES :
PHYSICAL REQUIREMENTS TO PERFORM JOB DUTIES :
EDUCATION AND / OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES :
Company Description
Part of the Forever Living family of companies, Aloe Vera of America manufactures and distributes Forever Living products to over 150 countries. Forever's Aloe is carefully grown and cultivated in plantations in Mission, TX and the Dominican Republic, to our facility to produce the best products possible. An independent distributor of natural health and beauty products of Forever Living. The best sources for health and beauty and sharing them with the world. Our complete family of Aloe Vera drinks, skincare products, and cosmetics brings the remarkable properties of aloe to the entire body. Add that to our full line of nutritional supplements and products from the beehive, and you have a complete system for naturally achieving better health and beauty.
Company Description
Part of the Forever Living family of companies, Aloe Vera of America manufactures and distributes Forever Living products to over 150 countries. Forever's Aloe is carefully grown and cultivated in plantations in Mission, TX and the Dominican Republic, to our facility to produce the best products possible. An independent distributor of natural health and beauty products of Forever Living. The best sources for health and beauty and sharing them with the world. Our complete family of Aloe Vera drinks, skincare products, and cosmetics brings the remarkable properties of aloe to the entire body. Add that to our full line of nutritional supplements and products from the beehive, and you have a complete system for naturally achieving better health and beauty.