Regulatory Affairs Manager jobs in Arlington, VA

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.

  • 18 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...
  • 20 Days Ago

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Regulatory Affairs Manager - CMC
  • Amgen
  • Washington, DC FULL_TIME
  • HOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion ...
  • 14 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...
  • 24 Days Ago

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Regulatory Affairs Manager
  • Immune Deficiency Foundation
  • Washington, DC FULL_TIME
  • Summary of Position: The Regulatory Affairs Manager monitors regulatory issues within designated areas and identifies opportunities to engage with government agencies including those within the Depart...
  • 1 Month Ago

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0 Regulatory Affairs Manager jobs found in Arlington, VA area

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Senior Research Analyst
  • Institute for Justice
  • Arlington, VA
  • Do you want to use your empirical research skills to advance individual rights? This is what the Institute for Justice’s...
  • 4/18/2024 12:00:00 AM

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EHS Regulatory Consultant
  • Enhesa
  • Arlington, VA
  • Who We Are: Enhesa is the market leader in global environmental, health and safety (EHS) law consulting. As a dynamic an...
  • 4/18/2024 12:00:00 AM

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QA/RA Manager
  • JCW
  • Washington, DC
  • Posted: 08/04/2024 Salary: - Location: Washington, District Of Columbia, United States Job Type: Permanent/Fixed Term Ou...
  • 4/18/2024 12:00:00 AM

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Senior Data Analyst
  • Eccalon, LLC
  • Arlington, VA
  • Location: Must be willing to go to Crystal City, VA 2-3 times a week. Clearance: Must have a Secret Clearance Opportunit...
  • 4/18/2024 12:00:00 AM

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Program Specialist $20.44
  • Melwood
  • Arlington, VA
  • Job Description Job Description PROGRAM SPECIALIST -7:30am-4:30pm MELWOOD VIRGINIA DAY SUPPORT SERVICES Melwood's Vision...
  • 4/18/2024 12:00:00 AM

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Program Analyst, USAF Budget & Acquisitions
  • Aeyon
  • Arlington, VA
  • DOD Program Analyst, Air Force Hybrid @ Pentagon (2x's per week) Must have DOD Clearance Job Description: The Air Force ...
  • 4/17/2024 12:00:00 AM

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Director of Legislation, Policy and Alliances
  • Patients For Affordable Drugs
  • Washington, DC
  • Director of Legislation, Policy and Alliances About the Organization Patients For Affordable Drugs is the only national ...
  • 4/16/2024 12:00:00 AM

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Director of Legislation, Policy and Alliances
  • Patients For Affordable Drugs
  • Washington, DC
  • Director of Legislation, Policy and Alliances About the Organization Patients For Affordable Drugs is the only national ...
  • 4/14/2024 12:00:00 AM

Arlington County is located in northeast Virginia and is surrounded by Fairfax County and the Falls Church to the southwest, the City of Alexandria to the southeast, and Washington, D.C. to the northeast directly across the Potomac River, which forms the county's northern border. Other landforms also form county borders, particularly Minor's Hill and Upton's Hill on the west. According to the U.S. Census Bureau, the county has a total area of 26.1 square miles (67.6 km2), of which 26.0 square miles (67.3 km2) is land and 0.1 square miles (0.3 km2) (0.4%) is water. It is the smallest county by...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$153,326 to $216,275
Arlington, Virginia area prices
were up 1.3% 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