Regulatory Relations Specialist jobs in Chicago, IL

Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)

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Marketing Operations Specialist/Manager (Remote Based - Part Time to Full Time)
  • OneSource Regulatory
  • Chicago, IL 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.

  • 22 Days Ago

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Hospitality Publicist + Social Media, Marketing Specialist
  • H2 Public Relations
  • Chicago, IL FULL_TIME
  • CHICAGO | JR PUBLICIST // SOCIAL MEDIA MARKETING ASSISTANTNOW HIRING FOR APRIL 2024 H2 Public Relations is opening applications for a full-time Jr Publicist, Social Media Marketing Assistant in the Ch...
  • 10 Days Ago

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Regulatory Operations Submissions Manager - OneSource Regulatory
  • OneSource Regulatory
  • Chicago, IL FULL_TIME
  • Join the OSR Team to transform Regulatory Operations project submission management and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companies implement the correct solution...
  • 22 Days Ago

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Regulatory Operations Project Manager - OneSource Regulatory
  • OneSource Regulatory
  • Chicago, IL FULL_TIME
  • Join the OSR Team to transform Regulatory project management and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companies implement the correct solutions, processes, standard...
  • Just Posted

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Regulatory Operations Submissions Publisher - OneSource Regulatory
  • OneSource Regulatory
  • Chicago, IL FULL_TIME
  • Join the OSR Team to transform Regulatory submissions publishing and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companies implement the correct solutions, processes, stan...
  • 6 Days Ago

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Regulatory Specialist
  • OSI Group
  • Aurora, IL FULL_TIME
  • This role will onboard new products from idealization to production. This role will also need to communicate with R&D, sales, production, FDA, USDA and ingredient suppliers to retrieve key information...
  • 18 Days Ago

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0 Regulatory Relations Specialist jobs found in Chicago, IL area

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Regulatory Specialist
  • Veralto Corp.
  • Wood Dale, IL
  • Imagine a world where everyone has access to clean water, safe food and medicines, and trusted essential goods. That is ...
  • 3/28/2024 12:00:00 AM

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Food Regulatory Specialist
  • Talento Search Group
  • Skokie, IL
  • Job Description Job Description Talento Search Group has an opening for a Food Regulatory Specialist in the Skokie, Illi...
  • 3/28/2024 12:00:00 AM

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Senior Staff Regulatory Specialist, Pharmaceuticals
  • Stryker
  • Cary, IL
  • Work Flexibility: Hybrid Stryker is one of the world's leading medical technology companies and, together with its custo...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Lake Forest, IL
  • Regulatory Affairs Specialist – Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medi...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Performance Health
  • Warrenville, IL
  • Performance Health is seeking a Regulatory Affairs Specialist to join our team. This role is responsible for establishin...
  • 3/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Sterling Engineering, Inc.
  • Schaumburg, IL
  • Title: Regulatory Affairs Specialist Location: Schaumburg, IL Hire Type: Direct Hire Overview: Sterling has helped build...
  • 3/26/2024 12:00:00 AM

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Sr. Regulatory Affairs Specialist
  • Medline Industries
  • Winnetka, IL
  • JOB SUMMARY: Remote work eligible except in Colorado and Connecticut. Under limited supervision, the Senior Regulatory S...
  • 3/25/2024 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...
  • 3/24/2024 12:00:00 AM

Chicago (/ʃɪˈkɑːɡoʊ/ (listen), locally also /-ˈkɔː-/), officially the City of Chicago, is the most populous city in Illinois, as well as the third most populous city in the United States. With an estimated population of 2,716,450 (2017), it is the most populous city in the Midwest. Chicago is the principal city of the Chicago metropolitan area, often referred to as Chicagoland, and the county seat of Cook County, the second most populous county in the United States. The metropolitan area, at nearly 10 million people, is the third-largest in the United States, and the fourth largest in North A...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$78,305 to $107,499
Chicago, Illinois area prices
were up 0.8% from a year ago

Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards.  This includes assisting with the management of regulatory examinations, inquiries and meetings.  Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020