Regulatory Affairs Specialist jobs in Arizona

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Marketing Operations Specialist/Manager (Remote Based - Part Time to Full Time)
  • OneSource Regulatory
  • REMOTE, AZ FULL_TIME|PART_TIME
  • Marketing Operations Manager  - OneSource Regulatory

    Join the OSR Team to transform Marketing/Commercial Operations and the way you work.


    About OneSource Regulatory

    OneSource Regulatory™ helps companies implement the correct solutions, processes, standards, systems, templates, and best practices for effective Regulatory Operations.  With the right Regulatory Operations group, our clients can achieve high quality document management, data management, and regulatory agency submissions.


      Today we provide the following exemplary Marketing/Commercial operations services:

    • Commercial Operations Infrastructure Build & Support Project Management - (Policy, Process, and Procedure Development)
    • Promotion Review Committee (PRC) Process Management
    • Technical E-Review System Implementation
    • Marketing/Promotional Materials Execution Project Management (Production and Dissemination of Materials)
    • HCP & Patient Speaker Bureau and Program Operations Management
    • Medical Congress Planning (Exhibits, Meetings & Events Management)
    • Vendor/External Partner Procurement & Management


    What You’ll Do

    Do you want the opportunity to work with a diverse group of pharmaceutical companies and provide commercial marketing support for some of the most innovative products in the industry - from the comfort of your home?

    OneSource Regulatory (OSR), is seeking qualified Marketing Operations Managers  based in the US.  You should be a collaborative team member who provides the following services to our clients and their agency partners:

    • Coordination and oversight of the promotion review process as well as other promotion related processes for assigned brands or therapeutic categories
    • Responsible for forecasting promotion review team needs, through collaboration with sales communications, training, brand managers, and other marketing support functions
    • Lead all prioritization discussions for the assigned promotion review team and communicate agreed upon agendas to reviewers and job owners who will be presenting during the meeting
    • Provide counsel to job owners on planning for the review process including timing considerations, type of review to consider, and guidance documents to review
    • Provide oversight of materials being added to the promotion review team agenda to ensure that minimum quality and promotion review guidance has been followed
    • Facilitate promotion review team meetings to ensure meetings are efficient and conducted according to guidance
    • Communicate information provided during promotion review meetings to the broader team when appropriate
    • Clarify, review, reconcile, and document the comments on review materials during live PRC meetings & ensure final approval from PRC reviewers
    • Oversee the copy proofing process and production process of final approved materials with agency/external partners
    • Interact with Agency Partners and Regulatory/Regulatory Operations Managers for the submission of promotional materials to OPDP for initial use (Form FDA 2253)
    • Partner with job owners and other stakeholders in the execution of job reapprovals and tactics related to label changes for assigned brands

     

    Qualifications:

    • Bachelor degree is required (Focus in Business, Medical, Science, Marketing, or Communications is preferred)
    • 10 years of related experience in the pharmaceutical/ biotech industry is required (For Sr level team leader roles) - May consider related experience from healthcare advertising agency
    • 7 years related experience in the pharmaceutical/ biotech industry is required (for individual contributor roles on the team) - May consider related experience from healthcare advertising agency
    • Functional experience in regulatory, medical, pharmaceutical marketing operations, sales or communications preferred
    • Product launch or advertising agency account management experience is a plus.
    • Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion
    • Understanding of pharmaceutical review and approval process is preferred
    • Deep understanding of the advertising/creative development process
    • Strong project and process management experience (in pharma industry preferred)
    • Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. - Proficiency in Veeva Vault Promo Mats or other electronic review platforms

     

    You should have a strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.


    The OneSource Regulatory team is comprised of the top experts in Marketing/Commercial Operations.  OSR team members have an average of 15 years of industry experience in large, mid-size and small companies across every therapeutic area.


    At OSR, you will be offered interesting and challenging work, and your position will come with a competitive salary, a flexible schedule and innovative incentive programs that reward your contributions and innovations.  You will have the opportunity for personal and professional development through internal coaching and mentoring, in addition to the opportunity to attend key external events.


    Learn more about OSR by visiting our website:  www.OneSourceRegulatory.com


    Questions?  Email us at info@OneSourceRegulatory.com

     

    Interested in joining the OSR Team? 

    Provide your information through the BambooHR form below.

  • 25 Days Ago

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Regulatory Affairs Manager
  • Tessenderlo Group
  • Phoenix, AZ FULL_TIME
  • Company Description Tessenderlo Kerley, Inc. is a company of diverse businesses unified by shared values. We serve the agricultural, mining, industrial, and water reclamation markets with a broad rang...
  • 1 Day Ago

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Indian Self-Determination Specialist
  • Interior, Bureau of Indian Affairs
  • Phoenix, AZ FULL_TIME
  • This position is located with the Bureau of Indian Affairs, Western Region in Phoenix, Arizona. The incumbent will implement P.L. 93-638 and P.L. 100- 472, and the regulations that these two laws have...
  • 9 Days Ago

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Realty Specialist (Contracts Management)
  • Interior, Bureau of Indian Affairs
  • Phoenix, AZ FULL_TIME
  • This position is located with the Bureau of Indian Affairs, Western Region in Phoenix, Arizona. The incumbent will manage complex real estate transactions for extensive Indian trust land. This is a Ba...
  • 9 Days Ago

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INDIAN SELF-DETERMINATION SPECIALIST
  • Interior, Bureau of Indian Affairs
  • Parker, AZ FULL_TIME
  • Summary This position is located with the Bureau of Indian Affairs, Superintendent, Colorado River Agency in Parker, Arizona. Assists in the program facilitation and coordination of the Agency Self-De...
  • 17 Days Ago

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Natural Resources Specialist
  • Interior, Bureau of Indian Affairs
  • Keams Canyon, AZ FULL_TIME
  • Summary This position is located with the Bureau of Indian Affairs, Superintendent, Hopi Agency in Keams Canyon, Arizona. This position is resposible for overall soil and water conservation, rangeland...
  • 1 Month Ago

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Athens, GA
  • Responsibilities: Collect and coordinate information and prepare regulatory documentation for submission to regulatory a...
  • 3/29/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Sterling Engineering
  • Addison, IL
  • Title: Regulatory Affairs Specialist Location: Schaumburg, IL Hire Type: Direct Hire Overview: Sterling has helped build...
  • 3/29/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Sally Beauty Holdings, Inc.
  • Denton, TX
  • Review labels of private label products for regulatory compliance in the US and applicable international markets. Review...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Tampa, FL
  • Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electroni...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • ConvaTec
  • Lexington, MA
  • Product Regulatory Affairs work includes: Directing submission development of product registration, progress reports, su...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Akkodis
  • Irvine, CA
  • Akkodis is seeking an Regulatory Affairs Specialist for a company located in Candidates need to be local to a Irvine ,CA...
  • 3/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Tephra
  • Edison, NJ
  • Description: The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory...
  • 3/26/2024 12:00:00 AM

Arizona (/ˌærɪˈzoʊnə/ (listen); Navajo: Hoozdo Hahoodzo Navajo pronunciation: [xòːztò xɑ̀xòːtsò]; O'odham: Alĭ ṣonak Uto-Aztecan pronunciation: [ˡaɺi ˡʂonak]) is a state in the southwestern region of the United States. It is also part of the Western and the Mountain states. It is the sixth largest and the 14th most populous of the 50 states. Its capital and largest city is Phoenix. Arizona shares the Four Corners region with Utah, Colorado, and New Mexico; its other neighboring states are Nevada and California to the west and the Mexican states of Sonora and Baja California to the south and so...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$74,140 to $99,357

Regulatory Affairs Specialist in Petaluma, CA
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
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Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
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Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019