Regulatory Affairs Manager jobs in New York

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established 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 Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Regulatory Affairs Manager
  • Jobot
  • Sleepy Hollow, NY FULL_TIME
  • Join long-time OTC products company as a Regulatory Affairs Manager focusing in OTC Drugs, Medical Devices, in Tarrytown, NY

    This Jobot Job is hosted by: Julia Toms
    Are you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.
    Salary: $100,000 - $145,000 per year

    A bit about us:

    Our company brings product innovation and quality to over-the-counter healthcare products to better improve the lives of our customers and their families. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter healthcare products in North America that continually improves and creates products that match the ever-changing lifestyles and needs of people globally.

    Why join us?

    We offer medical, dental, vision, life, short and long term disability insurance, and a 401(k) retirement plan with a recently enhanced Company match.
    Our time-off programs are fairly typical, but employees do enjoy the week between Christmas and New Year's Day as a paid time-off benefit that doesn't get charged against vacation.
    Competitive Salary 20% Bonus for this role
    Generous PTO
    Other Perks:
    • Snacks
    • In-house gym


    Job Details

    Hybrid: Tarrytown, NY

    The Manager of Regulatory Affairs will report to the Sr. Director, Regulatory Affairs and, under the direction and guidance of the Sr. Director, will ensure the regulatory compliance of our products throughout the product development cycle and monitor regulatory developments that may impact the business. Product categories include OTC Medical Devices, OTC Drugs, Cosmetics, Dietary Supplements and EPA-regulated pesticides.

    Major Responsibilities/Activities
    • Foster close cooperative relationships with all functions in the company relative to regulatory compliance, including working with Product Development, Package Development, Legal, Quality Assurance and Marketing to execute all initiatives for assigned brands. (40%)
    • Provide regulatory guidance to product development teams for assigned brands, including claim substantiation, label reviews and advice on regulatory submissions. (25%)
    • Maintain and prepare NDA supplements and/or 510(k) applications as well as other regulatory documentation for assigned brands and products. (15%)
    • Assist in the refinement and enforcement of Regulatory policies with particular emphasis on compliance to the company’s Quality System, external regulatory standards (e.g., ISO 13485), and relevant regulations. (10%)
    • Monitor global regulatory developments affecting products through participation in industry associations, monitoring of newsletters and government websites and other methods, and communicate significant issues to management. Ensure that the activities of assigned industry task forces and committees reflect priorities. (10%)


    Minimum Requirements
    EDUCATION/CERTIFICATION:
    • Bachelor's Degree in scientific or health-related field; Master's degree preferred

    REQUIRED KNOWLEDGE:
    • Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
    • Strong knowledge of OTC drug and device regulations, including labeling requirements
    • Working knowledge of U.S. clinical research and claims support
    • Excellent written and verbal communication skills
    • Demonstrated ability to work with people in an effective and positive manner

    EXPERIENCE REQUIRED:
    • 6 years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
    • Drug or medical device submission and/or maintenance experience

    The Manager, Regulatory Affairs will provide support to Operations, Quality, Graphics, Packaging, Product Development, Legal and Marketing functions:
    • Serve as the regulatory representative on identified product development teams
    • Create or review U.S. & Canada regulatory submissions that meet company and regulatory agency requirements
    • Develop and implement company and departmental SOPs and provide training/compliance
    • Propose and meet realistic timelines for regulatory submissions and approvals
    • Keep up to date on changes in regulatory requirements related to OTC drug, device, and dietary supplement regulations and communicate these changes within company
    • Represent company on assigned industry task forces and ensure that company needs are addressed
    • Improve work processes for continued regulatory compliance and departmental efficiencies
    • Ensure compliance with applicable U.S. & Canada regulations, laws, and standards


    Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.

    Benefits:
    401K, Employee Events, Employee Referral Program, Flexible Schedules, Free Food and Coffee, Game Rooms, Life Insurance, Maternity/Paternity Paid Leave, Medical, Dental and Vision, On Site Cafeteria, Paid Holidays, Paid sick days, Parking , Performance bonus, Professional Development, Retirement / Pension Plans, Vacation/paid time off, Work From Home


    About the Company:
    Jobot


     



    Company Size:
    500 to 999 employees


    Industry:
    Energy and Utilities


    Founded:
    2018


    Website:
    https://jobot.com/


  • 1 Day Ago

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Regulatory Affairs Manager
  • Jobot
  • Armonk, NY FULL_TIME
  • Join long-time OTC products company as a Regulatory Affairs Manager focusing in OTC Drugs, Medical Devices, in Tarrytown, NYThis Jobot Job is hosted by: Julia TomsAre you a fit? Easy Apply now by clic...
  • 1 Day Ago

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Manager CMC Regulatory Affairs
  • Regeneron Pharmaceuticals Inc.
  • Rensselaer, NY FULL_TIME
  • The Manager CMC Regulatory Affairs is responsible for interpreting the current, approved and planned clinical regulatory landscape by contributing to the management of the regulatory submission form p...
  • 1 Day Ago

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CMC Regulatory Affairs Manager
  • Katalyst Healthcares & Life Sciences
  • Sleepy Hollow, NY FULL_TIME
  • Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accurac...
  • 1 Day Ago

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Regulatory Affairs Manager
  • Jobot
  • White Plains, NY FULL_TIME
  • Join long-time OTC products company as a Regulatory Affairs Manager focusing in OTC Drugs, Medical Devices, in Tarrytown, NYThis Jobot Job is hosted by: Julia TomsAre you a fit? Easy Apply now by clic...
  • 2 Days Ago

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Manager/Sr. Manager, Regulatory Affairs
  • Zentalis
  • Remote, NY FULL_TIME
  • JOB SUMMARY: Responsible for drafting cover letters for submissions and for being the regulatory point of contact internally for DSURs and IBs and for other documents as needed. Supports the implement...
  • 16 Days Ago

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Regulatory Affairs Manager - Drug Development
  • Gan & Lee Pharmaceuticals
  • Bridgewater, NJ
  • Summary This position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the develop...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Daikin Comfort
  • Waller, TX
  • Regulatory Affairs Manager Daikin Comfort Technologies Manufacturing, L.P. is seeking a skilled individual for our Regul...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 3/27/2024 12:00:00 AM

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Global Regulatory Affairs Manager II
  • Yoh, A Day & Zimmermann Company
  • Fort Worth, TX
  • Job Description Job Description Global Regulatory Affairs Manager II - Fort Worth 9 month contract W2 Pay Rate: $55.00 -...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Beacon Hill Staffing Group
  • San Fernando, CA
  • **Role is Fully Onsite to Northridge, CA** ROLE SUMMARY To support the our business in maintaining regulatory compliance...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Advanced Respiratory Technologies, Inc.
  • Pittsburgh, PA
  • Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Alameda Health System
  • Oakland, CA
  • Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditatio...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager - Drug Development
  • Gan & Lee Pharmaceuticals
  • Somerville, NJ
  • Summary This position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the develop...
  • 3/24/2024 12:00:00 AM

New York is a state in the Northeastern United States. New York was one of the original thirteen colonies that formed the United States. New York covers 54,555 square miles (141,300 km2) and ranks as the 27th largest state by size.[3] The highest elevation in New York is Mount Marcy in the Adirondacks, at 5,344 feet (1,629 meters) above sea level; while the state's lowest point is at sea level, on the Atlantic Ocean. In contrast with New York City's urban landscape, the vast majority of the state's geographic area is dominated by meadows, forests, rivers, farms, mountains, and lakes. Most of...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$146,607 to $206,787

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019