Regulatory Affairs Director jobs in Florida

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Director Regulatory Affairs
  • It Works
  • Bradenton, FL FULL_TIME
  • It Works! Director Regulatory Affairs

     

    This is a hybrid position requiring 3 days in the Palmetto, Florida office/2-days remote. Candidates must be local or relocate to be considered for this role.

    * All applicants must be authorized to work in the US as we currently do not sponsor employment.

     

    RESPONSIBILITIES:

     

    This position works cross functionally with multiple internal and external functions and has primary responsibility for providing scientific and regulatory expertise to ensure compliance with existing products, and to also facilitate and enable compliant new product introductions, product changes, marketing strategies, and support legal matters.


    • Serve as the company's regulatory and scientific expert by remaining current with new and future product and regulatory trends, provide training, direction, and guidance to internal stakeholders on existing, new, and emerging regulations, ingredients, and trends, and making recommendations for new product lines and claims to create world-class product offerings.


    • Lead and manage product formulation and raw materials reviews for new or existing products, to ensure they meet US & Canadian regulatory requirements, and that all supporting documentation is suitably maintained (e.g., Formula / Specification Sheets / Allergen Statements etc.).


    • Ensure that on-product labeling, associated nutritional / supplement facts panels, and feature / benefit claims for existing products, new product introductions and product changes meet US & Canadian regulatory requirements, and provide on-product labeling claim risk assessments.


    • Collaborate with leadership, marketing, sales, and legal to facilitate regulatory compliance of sales and marketing collateral and communication materials (website copy, videos, distributor sales tools, presentations etc.). This includes training and education of internal cross-functional groups and providing risk assessments.


    • Support Customer Service and Product Coach initiative by providing scientific and regulatory responses to product enquiries from the field.


    • Support legal counsel specifically as it relates to regulatory or scientific explanations and status of product ingredients, product claims, labels, and advertising.


    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

     

    Bachelor’s degree in Food Science, Regulatory Affairs or related field

    10 years of Regulatory Compliance / Regulatory Affairs.

    Strong knowledge of FDA Food and Dietary Supplement regulations including product labeling and claims.

    Knowledge of Canadian NHP and Food regulation

    Strong attention to detail

    Ability to communicate technical ideas and information clearly and effectively.

     

    About It Works!

    At IT WORKS!, our mission is to transform lives through a thriving global community with results-driven products and an unmatched business opportunity.


    IT WORKS! has a sales force of thousands of Independent Distributors in 16 countries and a passionate Corporate Team located at our global headquarters in Palmetto, Florida. Since 2001, we have offered simple solutions that can be added to any routine, are backed by science, and deliver incredible results through four categories: active lifestyle, gut health, weight loss, and beauty.


    IT WORKS! is honored to be one of the fastest-growing private companies on the Inc. 500 list for three consecutive years, as well as No. 27 on the Direct Selling News Global 100—the annual industry ranking produced by Direct Selling Magazine.


    The IT WORKS! Way

    The "IT WORKS! Way" is to uphold our standard of greatness in everything we do: from creating products that help you meet your wellness goals to offering a community of support while you work your way to the life of your dreams! You're never alone on your journey—at IT WORKS!, we are one.



  • 1 Month Ago

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Director, US Regulatory Affairs & Global
  • System One
  • De Land, FL CONTRACTOR
  • Position: CONTRACTOR -- Director, US Regulatory Affairs & Global Development Projects (GDP) Location: Remote (East or Central Time Zone) / Prefers local Contract: 12mns Pay Rate: 80/hr - 95/hr Purpose...
  • Just Posted

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Associate Director, Regulatory Affairs - Plasma Services
  • ADMA BIOMANUFACTURING LLC
  • Boca Raton, FL OTHER
  • Job Details Job Location: ADMA Biologics - Boca Raton, FL Salary Range: Undisclosed Travel Percentage: Up to 50% Job Shift: Day DescriptionADMA Biologics is a biopharmaceutical company relentlessly co...
  • 29 Days Ago

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Sr. Manager, Regulatory Affairs
  • Axogen
  • Tampa, FL FULL_TIME
  • Axogen is hiring for a Sr. Manager of Regulatory in Tampa, FL, Alachua, FL, or Vandalia, OH! Job Summary of the Sr. Manager of Regulatory The Sr. Manager, Regulatory will provide direction and leaders...
  • 16 Days Ago

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Tampa, FL FULL_TIME
  • Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. Leader in the development of dossiers for registration of product...
  • 20 Days Ago

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Manager, Regulatory Affairs
  • ADMA BIOMANUFACTURING LLC
  • Boca Raton, FL OTHER
  • Job Details Level: Management Job Location: ADMA Biologics - Boca Raton, FL Position Type: Full Time Education Level: 4 Year Degree Salary Range: Undisclosed Travel Percentage: None Job Shift: Day Des...
  • 21 Days Ago

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Head of Regulatory Affairs
  • Einride
  • Austin, TX
  • Want to be part of transforming road freight - for good? Einride is showing the world a new way to move, based on the la...
  • 4/24/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Dyne Therapeutics
  • Waltham, MA
  • Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-tran...
  • 4/24/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Meet
  • Associate Director/Director, Regulatory Affairs (Oncology) Remote - East Coast Candidates Meet has partnered with a very...
  • 4/24/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 4/23/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs
  • Accordance Search Group
  • Cambridge, MA
  • What this position is all about: We are looking for a strategic and results-driven Head of Regulatory Affairs (level com...
  • 4/23/2024 12:00:00 AM

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Sr. Manager Federal Regulatory Affairs / Director, Federal Regulatory Affairs
  • Constellation Energy Generation, LLC.
  • Washington, DC
  • COMPANY OVERVIEW As the nation's largest producer of clean, carbon-free energy, Constellation is a company purposely-bui...
  • 4/22/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Accordance Search Group
  • Somerville, MA
  • What if you could join a company rapidly advancing its first candidate to clinic and play a critical role in bringing ne...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Director
  • Hiring Now!
  • Boston, MA
  • About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehens...
  • 4/21/2024 12:00:00 AM

Florida (/ˈflɒrɪdə/ (listen); Spanish for "land of flowers") is the southernmost contiguous state in the United States. The state is bordered to the west by the Gulf of Mexico, to the northwest by Alabama, to the north by Georgia, to the east by the Atlantic Ocean, and to the south by the Straits of Florida. Florida is the 22nd-most extensive (65,755 sq mi or 170,300 km2), the 3rd-most populous (21,312,211 inhabitants), and the 8th-most densely populated (384.3/sq mi or 148.4/km2) of the U.S. states. Jacksonville is the most populous municipality in the state and the largest city by area in th...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$160,575 to $228,696

Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019