Regulatory Affairs Manager jobs in Baltimore, MD

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
  • Tobacco Technology
  • Eldersburg, MD FULL_TIME
  • About Tobacco Technology, Inc (TTI): More than 150 years ago, we began our tobacco journey as tobacco farmers, eventually becoming a premier exporter of leaf tobacco in the USA. And for the last 50 years, we’ve been perfecting tobacco taste with a focus on flavor innovation. Today, we remain a family-owned and operated business. It’s in our DNA.
    TTI is a key player in the tobacco, e-liquids, and CBD flavoring industry, with a focus on creating the next unique signature flavor for leading-edge clients. Our highly-skilled flavor experts in research and development, regulatory compliance, and sales are taking our company to the next level and our modern manufacturing facility was designed to meet and exceed global regulatory requirements.
    Summary: The Regulatory Manager is responsible for providing guidance, developing regulatory strategies, and risk assessment for our products globally. This role will work closely with Research & Development, Quality Control, Project Management, and Supply Chain.
    Essential Job Responsibilities:
    • Creates and implements a strategic plan with developing sound regulatory strategy for our products.
    • Monitors, interprets, and implements current and new regulatory requirements for US and international customers.
    • Consults with R&D and Sales to ensure products in development comply with global Regulatory requirements in the markets in which they will be sold.
    • Prepares, submits, and maintains all required paperwork for global regulatory product compliance.
    • Ensures associated R&D protocols being used correlate with the various global standards/regulations required.
    • Assists with the Safety Data Sheets (SDS) process to ensure we are meeting all regulatory requirements.
    • Attends meetings, providing regulatory expertise and direction for products.
    • Responsible for ensuring all product literature, data, product and carton labels are reviewed and updated to remain compliant with global standards.
    • Anticipates, monitors, tracks, and analyzes policies, legislation, and regulations and provides consultation to the team on key developments that may be an impact to the company.
    • Communicates with regulatory authorities as needed.
    • Identifies opportunities for continuous improvement that have a significant impact and assists in developing or executing implementation plans.
    Skills, Knowledge, and Abilities:
    • Bachelor’s degree in a related field.
    • 5 years related regulatory compliance experience.
    • Global regulatory experience preferred.
    • Working knowledge of Microsoft Office.
    • Effective problem solver.
    • Excellent organizational skills and ability to work on several projects with tight timelines.
    • Excellent verbal and written communication skills.
    • Ability to work well under pressure and have excellent attention to detail.
    • Strong time management skills.
    • Ability to conduct appropriate research as needed.
    • Strong analytical skills for compliance.
    • Strong attention to detail and organization.
    • Ability to give and receive constructive feedback.
    • Demonstrated ability to work in a fast paced, results-oriented, challenging environment.
    • This position requires regular presence in the office.
    • Some travel may be required.
  • 1 Month Ago

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Director Regulatory Affairs
  • Flexible Packaging Association
  • Annapolis, MD FULL_TIME
  • About the Job The Flexible Packaging Association (FPA), an Annapolis-based trade association representing over 85,000 packaging professionals across the nation, is looking for a Director of Regulatory...
  • Just Posted

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Director of Regulatory Affairs
  • Johns Hopkins Medicine
  • Baltimore, MD FULL_TIME
  • Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure c...
  • 3 Days Ago

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Regulatory Affairs Specialist, Medical Device
  • Katalyst Healthcares & Life Sciences
  • Baltimore, MD FULL_TIME
  • Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have ...
  • 1 Month Ago

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Manager, External Affairs
  • Easton Utilities
  • Easton, MD FULL_TIME
  • If you know how to work as part of a diverse team, build relationships and have fun, Easton Utilities is the place for you! As an employee in one of our divisions - Electric, Gas, Water, Wastewater, C...
  • 1 Month Ago

U
Business Manager - Academic Affairs College of Arts and Sciences
  • University of Baltimore
  • Baltimore, MD FULL_TIME
  • excellent tuition remission benefitsoutstanding health benefits plans and ratesat least 11 paid holidays each year40 days of annual, personal, and sick leave each year, including 20 annual leave daysg...
  • 1 Month Ago

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0 Regulatory Affairs Manager jobs found in Baltimore, MD area

Baltimore (/ˈbɔːltɪmɔːr/) is the largest city in the state of Maryland within the United States. Baltimore was established by the Constitution of Maryland as an independent city in 1729. With a population of 611,648 in 2017, Baltimore is the largest such independent city in the United States. As of 2017[update], the population of the Baltimore metropolitan area was estimated to be just under 2.808 million, making it the 20th largest metropolitan area in the country. Baltimore is located about 40 miles (60 km) northeast of Washington, D.C., making it a principal city in the Washington-Baltimo...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$141,617 to $199,758
Baltimore, Maryland area prices
were up 1.5% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020