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Regulatory Affairs Manager Remote Jobs in Racine, WI

micro1 AI

Medical Writing Manager

Milwaukee, WI · Remote

$50 - $80/hr

Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

micro1 AI

Medical Writing Manager

Kenosha, WI · Remote

$50 - $80/hr

Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

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Regulatory Affairs Manager Remote information

See Racine, WI salary details

$27

$53

$81

How much do regulatory affairs manager remote jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for regulatory affairs manager remote in Racine, WI is $53.42, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $62.45 per hour, depending on experience, location, and employer.

What does a regulatory affairs manager do when working remotely?

A Regulatory Affairs Manager working remotely is responsible for ensuring that their company's products comply with all relevant regulations and standards set by governmental and regulatory bodies. They prepare and submit documentation, monitor changes in regulations, and communicate with regulatory agencies to facilitate product approvals or renewals. While remote, they use digital tools to collaborate with internal teams, manage compliance projects, and stay updated on industry changes. Their work ensures that products remain in the market legally and safely.

What are the key skills and qualifications needed to thrive as a regulatory affairs manager working remotely?

To excel as a Regulatory Affairs Manager (Remote), you need a deep understanding of regulatory guidelines, compliance procedures, and industry standards, typically supported by a degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and certifications like RAC (Regulatory Affairs Certification) are highly valuable. Outstanding organizational skills, attention to detail, and strong communication abilities help you effectively interpret regulations and collaborate across teams. These competencies ensure products meet legal requirements efficiently, minimizing risks and facilitating successful market access.

How does a regulatory affairs manager working remotely typically collaborate with cross-functional teams to ensure compliance?

As a remote Regulatory Affairs Manager, you will regularly interact with cross-functional teams such as R&D, Quality Assurance, Clinical, and Marketing through virtual meetings, email, and collaborative project management tools. Effective communication and proactive coordination are key, as you may need to clarify regulatory requirements, review submission documents, and provide compliance guidance across different time zones. Building strong relationships and maintaining clear documentation helps facilitate seamless collaboration, ensuring all stakeholders are aligned on regulatory expectations and deadlines.

What is the difference between Regulatory Affairs Manager Remote vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Manager RemoteRegulatory Affairs Specialist
CredentialsBachelor's degree, often advanced certifications (RAC)Bachelor's degree, some certifications preferred
Work EnvironmentRemote, managerial oversight, strategic planningRemote or on-site, focused on document preparation and compliance
Industry UsageUsed across pharmaceutical, biotech, medical device companiesCommon in similar industries, often reporting to managers
Search & Comparison IntentUnderstanding managerial roles and responsibilitiesFocus on entry to mid-level regulatory tasks

The Regulatory Affairs Manager Remote oversees regulatory strategies and compliance at a managerial level, often requiring advanced certifications. The Regulatory Affairs Specialist handles specific regulatory tasks, such as preparing documentation and ensuring compliance, typically with less managerial responsibility. Both roles are essential in regulated industries like pharma and biotech, with the manager focusing on strategy and leadership, while the specialist executes detailed regulatory activities.

What job categories do people searching Regulatory Affairs Manager Remote jobs in Racine, WI look for?

The top searched job categories for Regulatory Affairs Manager Remote jobs in Racine, WI are:

What cities near Racine, WI are hiring for Regulatory Affairs Manager Remote jobs?

Cities near Racine, WI with the most Regulatory Affairs Manager Remote job openings:

Regulatory Affairs Manager Remote jobs near you

Medical Writing Manager

micro1 AI

Milwaukee, WI • Remote

$50 - $80/hr

Part-time

Posted 17 days ago

Job description

Role Title: Medical Writer / Clinical Document Author


Role Type: Contractor


Location: Remote


micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
  2. Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
  3. Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
  4. Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
  5. Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
  6. Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.


Preferred Qualifications

  1. Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
  2. Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
  3. Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
  4. Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
  5. Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
  6. Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
  7. Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.


Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.

Apply