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Regulatory Labeling Remote Jobs in Oregon (NOW HIRING)

Upstart

Senior Software Engineer, White Label Platform

OR · On-site +1

$122K - $161K/yr

... and regulations * Prior experience or demonstrated enthusiasm for working on internal tools ... Remote Travel requirements As a digital first company, the majority of your work can be ...

Med Communications

Pharmacovigilance Physician

Remote (United States) Department: Pharmacovigilance Reports To: Global Head of Pharmacovigilance ... U.S. and international product labeling documents * Regulatory authority safety information ...

Array

VP, Enterprise Client Success

OR · On-site +1

$200K/yr

Our private label offerings help drive revenue and increase engagement for our customers while ... As a remote-first company, we're focused on providing opportunities for high performing individuals ...

Autodesk

Senior Manager, Data Security

Portland, OR · On-site +1

$121K - $166K/yr

This role is remote-friendly within North America. For those who prefer in-office or hybrid work ... Partner with Legal, Privacy, Compliance, Engineering, and People teams to translate regulatory ...

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Regulatory Labeling Remote information

What is the difference between Regulatory Labeling Remote vs Regulatory Documentation Specialist?

AspectRegulatory Labeling RemoteRegulatory Documentation Specialist
CredentialsRegulatory or life sciences certifications often preferredSimilar certifications, often including regulatory affairs or compliance
Work EnvironmentPrimarily remote, collaborating with cross-functional teamsTypically office-based or hybrid, with some remote options
Industry UsageCommon in pharmaceutical, medical device, and biotech industriesUsed across similar industries, focusing on documentation management
Search & ComparisonOften compared for regulatory documentation roles with similar remote optionsRelated but more focused on documentation creation and management

Regulatory Labeling Remote and Regulatory Documentation Specialist roles share overlapping credentials and industry usage. However, Regulatory Labeling Remote emphasizes remote collaboration on labeling compliance, while Regulatory Documentation Specialist focuses on managing regulatory documents, often in a hybrid or office setting.

What are some typical challenges faced by professionals in remote regulatory labeling roles, and how can they be overcome?

Remote regulatory labeling professionals often encounter challenges like coordinating across global time zones, ensuring clear communication with cross-functional teams, and staying updated on constantly evolving regulations. To overcome these, it's essential to establish strong digital communication practices, use collaborative project management tools, and dedicate time for ongoing regulatory training. Building relationships with colleagues in regulatory affairs, quality, and product management also helps streamline the review and approval process for labeling content.

What are the key skills and qualifications needed to thrive as a regulatory labeling specialist remote?

To thrive as a Regulatory Labeling Specialist, you need expertise in regulatory requirements, strong attention to detail, and a background in life sciences or a related field. Familiarity with labeling management systems, regulatory submission platforms, and knowledge of global labeling regulations are typically required, often supported by certifications such as RAC (Regulatory Affairs Certification). Exceptional written communication, collaboration, and project management skills set top candidates apart. These competencies ensure accurate and compliant product labeling, helping companies meet regulatory standards and bring products to market efficiently.

What is a regulatory labeling remote position?

A Regulatory Labeling Remote position involves ensuring that product labels meet all regulatory requirements set by health authorities, often for pharmaceuticals, medical devices, or food products. Professionals in this role review, develop, and maintain labeling documentation to ensure accuracy and compliance with global or regional regulations. Working remotely allows them to perform these tasks from a location outside the traditional office, using digital tools to communicate and collaborate with regulatory, legal, and product development teams. They are essential for ensuring that products can be legally marketed and used safely by consumers.
What are popular job titles related to Regulatory Labeling Remote jobs in Oregon? For Regulatory Labeling Remote jobs in Oregon, the most frequently searched job titles are:
What job categories do people searching Regulatory Labeling Remote jobs in Oregon look for? The top searched job categories for Regulatory Labeling Remote jobs in Oregon are:
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Regulatory Labeling Remote jobs near you

Director, Regulatory Affairs Advertising and Promotion

Ultragenyx Pharmaceutical

OR • Remote

$149K - $197K/yr

Full-time

Posted yesterday

New

Job description

Position Summary:

ultrafocused - Work together to fearlessly uncover new possibilities

The Director of Regulatory Affairs Ad/Promo will serve as a subject matter expert for regulatory review of advertising and promotional, and non-promotional materials for the U.S. and Canada (CA) and provide regulatory leadership to the Materials Review Committee (MRC) to ensure all communications, advertising and promotional materials and programs throughout the product life cycle are compliant with applicable laws, regulations, and company policies.

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Serve as the MRC Chair and provide direction and regulatory expertise for promotional materials, medical, and payer communications.

2. Serve as primary contact with the FDA (OPDP/APLB) and PAAB as needed, including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material.

3. Review and approve Form FDA-2253 submissions.

4. Provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling to help ensure promotional materials are aligned with promotional regulations, corporate standards, and policies and business objectives.

5. Support the U.S. and CA commercial and medical teams, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on strategies and objectives and tactics.

6. Maintain current awareness of evolving agency regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the industry; communicate significant changes in Agency perspective to relevant stakeholders.

7. May lead cross-functional process improvements or other special projects.

8. Represent Regulatory Affairs Ad/Promo at regulatory sub-team and labeling meetings; provide strategic regulatory guidance.

9. Other duties as required.

Requirements:

Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD).

2. 10+ years of industry experience including 5+ years of advertising promotion experience.

3. Excellent verbal and written communication skills.

4. Attention to detail and ability to manage multiple priorities simultaneously.

5. Strong interpersonal skills with ability to demonstrate strategic and analytical thinking.

6. Demonstrate and proactively advocate working together in the spirit of transparency that encourages engagement, collaboration, and respectful interactions.

7. Experience chairing/leading review committees or other relevant regulatory governance committees.

8. Experience participating in cross-functional projects and teams.

9. Strong interpersonal skills and understanding of team dynamics.

10. Veeva PromoMats experience preferred.

11. When needed, ability to travel.

#LI-CS1, #LI-Remote

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