Regulatory Affairs Manager jobs in Maryland

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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Senior Editor, Books
  • Regulatory Affairs Professionals Society
  • Rockville, MD FULL_TIME
  • Location:  Rockville, MD (hybrid or fully remote) 

    Key skills:  Substantive editing, author management, content management 

    Experience:  8-10 years editorial experience in book publishing 

    Reports to:  Director, Publications 

    Start date:  February 2024 

    Applicants who are invited to interview will be asked to provide a writing sample. 

     

    The Role 

    Help support the professionals who bring lifesaving medications and medical devices to market! RAPS (the Regulatory Affairs Professionals Society) is seeking a senior editor to shepherd subject matter experts and shape the content they create for books and related products. 

     

    What you will do with us: 

    • Serve as editor on books published by RAPS. 
    • Evaluate book proposals and manuscripts; supervise the submission process and tracking system. 
    • Substantively edit manuscripts for factual accuracy, form, grammar/punctuation, adherence to proscribed style, and general readability. 
    • Oversee book contracts and author agreements. 
    • Serve as staff liaison to the volunteer Editorial Advisory Committee (EAC) on developing the annual book production calendar. 
    • Research and develop new books and resources on topics of interest to the regulatory community, including RAPS-published and co-published books. 
    • Work with graphic designers on book layout and design. 
    • Work with editorial freelancers on quality control. 
    • Liaison with the marketing team to ensure they are adequately backgrounded to develop compelling tactics to foster book sales.
    • Liaison with external organizations for potential co-promotion of books and other publications. 
    • Support other editorial and communications activities of the organization, as appropriate. 

     

    What you will bring to succeed: 

    • Bachelor’s degree in English, communications, journalism, or related; OR commensurate experience 
    • 8 to 10 years of editorial experience in book publishing 
    • Strong written and verbal communication skills 
    • Ability to establish working relationships both internally and externally 
    • Strong author management skills 
    • Highly skilled in time management and organization 
    • Multitasker; able to meet or exceed deadlines on multiple projects simultaneously 
    • Thorough understanding of print and electronic publication production processes 
    • Excellent attention to detail 
    • Proficiency in Microsoft Office 
    • Working knowledge of several professional editorial-style manuals 

    Preferred: 

    • Familiarity with regulatory, medical, and/or scientific topics 
    • Knowledge of InDesign, InCopy, or other layout production software 

     

    What RAPS offers: 

    • Flexible hybrid work environment 
    • Highly competitive, market-based salaries 
    • Annual merit-based salary adjustments 
    • Incentive pay/bonuses 
    • Reimbursement for job-related education training 
    • Fully paid LinkedIn Learning subscription 
    • Generous PTO accruement 
    • 10 annual paid holidays with extended holiday break 
    • Medical, dental, vision, & life insurance 
    • Short/long term disability 
    • 403(b) Retirement Plan with employer match 

     

    About RAPS 

    The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, DC, with chapters and affiliates worldwide.

     

    As an employer, RAPS encourages dedication to quality and member service. We support innovation and creativity, respect, and high ethical standards. We value learning and professional development and strive to maintain a safe and enjoyable work atmosphere that promotes collegiality.

     

    RAPS provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable laws. RAPS complies with applicable state and local laws governing nondiscrimination in employment in every location where the company has facilities.

     

    We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

  • 15 Days Ago

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Virtual Events Specialist
  • Regulatory Affairs Professionals Society
  • Rockville, MD FULL_TIME
  • Location: Rockville, MD (Remote or Hybrid) Experience: 4 years of event and volunteer management experience Reports to: Director of Education Programs The Role RAPS is seeking a Virtual Events Special...
  • 17 Days Ago

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MANAGER, REGULATORY AFFAIRS
  • tech-res
  • Bethesda, MD FULL_TIME
  • Job Title MANAGER, REGULATORY AFFAIRS Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory...
  • 1 Month Ago

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Manager, Regulatory Affairs
  • IMMUNOMIC THERAPEUTICS, INC.
  • Rockville, MD FULL_TIME
  • Job DescriptionWe are seeking a Manager of Regulatory Affairs to join our ITI team. The ideal candidate will have experience in development of regulatory documents for filing with the FDA (e.g., Meeti...
  • 21 Days Ago

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Regulatory Affairs Manager
  • Office of Intramural Training & Education
  • Jackson, MD FULL_TIME
  • About the position HJF is a 501(c)(3) nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and suppor...
  • 25 Days Ago

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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 ye...
  • 1 Month Ago

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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...
  • 4/16/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Yoh, A Day & Zimmermann Company
  • Los Angeles, CA
  • Yoh has an exciting, entry-level opportunity for a Regulatory Affairs Manager to join our client in the Cosmetics Indust...
  • 4/15/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Akston Biosciences Corporation
  • Beverly, MA
  • Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences ...
  • 4/15/2024 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...
  • 4/15/2024 12:00:00 AM

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Regulatory Affairs Manager
  • SPECTRAFORCE
  • Princeton, NJ
  • Title: Manager, Regulatory Affairs II Duration:02+ Years Location: Princeton, New Jersey, 08540 The role provides tactic...
  • 4/14/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Yoh, A Day & Zimmermann Company
  • El Segundo, CA
  • Job Description Job Description Yoh is looking for a Regulatory Affairs Manager to come in and join our Cosmetic Formula...
  • 4/14/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Tessenderlo Kerley, Inc.
  • Phoenix, AZ
  • Tessenderlo Kerley, Inc.is a company of diverse businesses unified by shared values. We serve the agricultural, mining, ...
  • 4/12/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Abbott Laboratories
  • Austin, TX
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 8/28/2023 12:00:00 AM

Maryland (US: /ˈmɛrələnd/ (listen) MERR-əl-ənd) is a state in the Mid-Atlantic region of the United States, bordering Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware to its east. The state's largest city is Baltimore, and its capital is Annapolis. Among its occasional nicknames are Old Line State, the Free State, and the Chesapeake Bay State. It is named after the English queen Henrietta Maria, known in England as Queen Mary. Sixteen of Maryland's twenty-three counties border the tidal waters of the Chesapeake Bay estuary and...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$142,030 to $200,341

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