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Regulatory affairs manager • plano tx

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Regulatory Affairs Manager

Regulatory Affairs Manager

Aloe Vera of America, Inc.Richardson, TX, US
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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 ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Regulatory Manager - HVAC (Remote)

Regulatory Manager - HVAC (Remote)

TTE Technology IncPlano, TX, US
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At TCL North America, innovation powers every product we create-including our rapidly expanding HVAC solutions.As a global leader in consumer technology, we are growing our presence in the North Am...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Senior Public Affairs Specialist

Senior Public Affairs Specialist

Cornerstone LeaguePlano, TX, US
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Communications & Media Relations.The Senior Public Affairs Specialist plays a pivotal role in shaping and executing Cornerstones public affairs strategy. This individual will work closely with t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Corporate Affairs Account Manager, Banking & Oversight

Corporate Affairs Account Manager, Banking & Oversight

USAAPlano, Texas, US
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We’re building something new—and we’re looking for bold, creative, and strategic talent to help shape it.USAA’s Corporate Affairs team is growing as part of an exciting transformation to strengthen...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Medicaid Regulatory Analyst

Medicaid Regulatory Analyst

Health Care Service CorporationTX, Richardson
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At HCSC, our employees are the cornerstone of our business and the foundation to our success.We empower employees with curated development plans that foster growth and promote rewarding, fulfilling...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Sr. Medicaid Regulatory Pricer Analyst

Sr. Medicaid Regulatory Pricer Analyst

ZelisPlano, TX, US
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Medicaid Regulatory Pricer Analyst will collaborate with the Zelis Regulatory Pricer Product team to further the company’s goals by researching, analyzing, documenting, and communicating rules, reg...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Regulatory Affairs Manager

Regulatory Affairs Manager

VirtualVocationsGarland, Texas, United States
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A company is looking for a Manager, Regulatory Affairs.Key Responsibilities Collaborate with internal departments to meet regulatory requirements and deadlines Manage, mentor, and develop direct...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
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Director, Medical Affairs

Director, Medical Affairs

Abbott LaboratoriesPlano, TX, United States
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At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Career development with an international company where you can g...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Compliance Manager, Regulatory Change Management

Compliance Manager, Regulatory Change Management

SoFiFrisco, TX
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We are seeking a highly motivated and experienced compliance professional to lead and execute regulatory change management activities as part of our enterprise Compliance Management System (CMS).Th...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Product Regulatory Sr. Counsel, Property

Product Regulatory Sr. Counsel, Property

CNAPlano, TX, USA
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Essential Duties & Responsibilities.Performs a combination of duties in accordance with departmental guidelines : .Provides business partners and other stakeholders with guidance and business insight...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Director Regulatory Compliance

Director Regulatory Compliance

Parkland Health and Hospital SystemPlano, Texas, United States
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Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
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Clinical Affairs Training Specialist

Clinical Affairs Training Specialist

RXSIGHT INCAddison, TX, US
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RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Regulatory Systems Manager

Regulatory Systems Manager

Comerica BankFrisco, TX
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This position manages regulatory rule review and writing, internal edit check logic and cross report requirements.Provides production support for bank regulatory reporting, including the quarterly ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Senior Manager Regulatory Affairs - Global Regulatory Services

Senior Manager Regulatory Affairs - Global Regulatory Services

AbbottPlano, Texas, United States
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Senior Manager Regulatory Affairs.Global Regulatory Services division within Leveraged Services.As a Senior Manager, the individual is to combine knowledge of scientific, regulatory and business is...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Technical Accounting & Regulatory Reporting Manager

Technical Accounting & Regulatory Reporting Manager

ZipRecruiterPlano, TX, United States
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Job DescriptionJob Description .Monet Bank is pioneering the future of banking and money movement—faster, cheaper, and crypto-. The passage of the Genius Act has enabled a future we want to explore ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Consumer Affairs Consultant I

Consumer Affairs Consultant I

Lennox InternationalRichardson, TX, US
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Works independently to handle a variety of incoming consumer inquiries on Residential HVAC products through a Contact Center. This position responds to questions and requests for information regardi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Director of Regulatory Affairs

Director of Regulatory Affairs

InogenPlano, TX, US
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This is a hybrid position at Inogen facilities located in Plano, TX or Beverly, MA.Responsible for the development and execution of regulatory strategy for Inogen products.The Director of Regulator...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Associate Manager, State and Local Government Affairs

Associate Manager, State and Local Government Affairs

Yum! BrandsPlano, TX, United States
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Ready to make your mark at an iconic global powerhouse? Join Yum! Brands - the parent company behind KFC, Pizza Hut, Taco Bell and Habit Burger & Grill - be a part of our reinvention for Greater Gr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Sr. Medicaid Regulatory Pricer Analyst

Sr. Medicaid Regulatory Pricer Analyst

Zelis Healthcare, LLCPlano, TX, United States
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Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers.We serve more than 750 payers, including the top five national health plans, regional hea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Leader, Regulatory Change Management

Leader, Regulatory Change Management

loanDepotPlano, Texas
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Leads the regulatory change management function, overseeing the review of mortgage servicing and originations regulatory updates, assessing their impact, and translating complex requirements into c...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Regulatory Affairs Manager

Regulatory Affairs Manager

Aloe Vera of America, Inc.Richardson, TX, US
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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 :

  • This position supervises employees in the department and is responsible for the performance management and hiring of employees within the department.
  • Execute performance management to include planning, monitoring, reviewing and evaluating performance of personnel.
  • Provide training, constructive feedback, and conduct performance reviews to direct reports.
  • Enforce company policies.
  • QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES :

  • Knowledge of 21 CFR Good Manufacturing Practices.
  • Knowledge of food and cosmetic labeling requirements such as HACCP regulations, and international regulations (the European Commission Directives such as Cosmetics Directive, REACH, Novel Foods, Nutrition labeling for Foodstuffs, and the Food Supplements Directive).
  • Knowledge of Regulatory Affairs, experience in Quality Assurance and Document Control.
  • Proficient in Microsoft Office.
  • Demonstrate organizational skills, strong verbal and written communication skills, and attention to detail.
  • Strong proofreading skills.
  • Must possess good interpersonal, communication (oral and written), organizational, and project planning skills.
  • PHYSICAL REQUIREMENTS TO PERFORM JOB DUTIES :

  • Stand / remain upright up to 4 hours at a time to perform audits.
  • Stand / remain upright up to 4 hours at a time to perform audits for up to 4 consecutive days.
  • Sit up to 4 hours at a time to process paperwork or research regulations.
  • Use keyboard and computer.
  • Reach forward and overhead, kneel, twist, turn and bend.
  • Visual acuity skills, needed to distinguish color, fine lines, and nonconformities in products and materials.
  • EDUCATION AND / OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES :

  • Bachelor's and / or Master’s degree in scientific or technical field from an accredited college, or equivalent combination of education and experience.
  • Minimum 5 years of experience in food, cosmetics, or related industry with experience creating and reviewing FDA-compliant labeling, working with R&D and vendors to create FDA-compliant formulas, and conducting quality and GMP audits.
  • RAPS, ASQ, HACCP or other industry-related certification, a plus.
  • 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.