Regulatory Affairs Manager jobs in Alexandria, 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.

  • 23 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...
  • 25 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 ...
  • 20 Days Ago

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Manager Regulatory Affairs
  • Philip Morris International
  • Washington, DC FULL_TIME
  • Be a part of a revolutionary change At PMI, we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose – to deliver a smoke-free futu...
  • Just Posted

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Regulatory Affairs Manager
  • System One
  • Rockville, MD OTHER
  • Title: Regulatory Affairs Manager Location: Remote Type: Permanent Salary: 120K – 140K plus 10-20% discretionary bonus Requirements Bachelor's degree in life sciences or related field; advanced degree...
  • Just Posted

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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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0 Regulatory Affairs Manager jobs found in Alexandria, VA area

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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 ...
  • 4/24/2024 12:00:00 AM

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PROGRAM/DATA MANAGEMENT SPECIALIST
  • HQ USAF and Support Elements
  • Arlington, VA
  • Summary Click on "Learn more about this agency" button below to view Eligibilities being considered and other IMPORTANT ...
  • 4/24/2024 12:00:00 AM

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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 Justices ...
  • 4/24/2024 12:00:00 AM

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Senior Manager, Regulatory Affairs - Cell Therapies (Remote-based)
  • Fresenius Kabi Usa Llc
  • Washington, DC
  • Job Summary The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help de...
  • 4/23/2024 12:00:00 AM

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Program Analyst (Policy)
  • Department of Defense Education Activity
  • Alexandria, VA
  • Summary About the Position: This position is located in Alexandria Virginia, in the Office of Chief of Staff Operations,...
  • 4/23/2024 12:00:00 AM

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Senior Policy Analyst
  • Bowhead
  • Arlington, VA
  • Overview: SENIOR POLICY ANALYST (NGB): Bowhead is seeking a strong Senior Policy Analyst to support Headquarters Nationa...
  • 4/23/2024 12:00:00 AM

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DOD Program Analyst
  • iTech AG
  • Arlington, VA
  • Description OVERVIEW The DoD Program Analyst will be serving as a subject matter expert assigned in support of Departmen...
  • 4/22/2024 12:00:00 AM

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FINANCIAL MANAGEMENT ANALYST
  • U.S. Marine Corps
  • Arlington, VA
  • Summary This is a public notice flyer to notify interested applicants of anticipated vacancies. Applications will not be...
  • 4/21/2024 12:00:00 AM

Alexandria is an independent city in the Commonwealth of Virginia in the United States. As of the 2010 census, the population was 139,966, and in 2016, the population was estimated to be 155,810. Located along the western bank of the Potomac River, Alexandria is approximately 7 miles (11 km) south of downtown Washington, D.C. Like the rest of Northern Virginia, as well as Central Maryland, modern Alexandria has been influenced by its proximity to the U.S. capital. It is largely populated by professionals working in the federal civil service, in the U.S. military, or for one of the many private...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$153,326 to $216,275
Alexandria, 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