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Global Labeling Manager Jobs in Indiana (NOW HIRING)

Specialty Foods Group

Global Export Manager

Delphi, IN · On-site

Global Export Manager Indiana Packers Corporation (IPC) is a fully integrated retail, foodservice and private label producer of fresh and processed meats based in Delphi, Indiana. Since the start of ...

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Global Labeling Manager information

What is a global labeling manager?

A Global Labeling Manager is a professional responsible for overseeing the development, maintenance, and regulatory compliance of product labeling for pharmaceutical or medical device products across multiple countries. They ensure that labels meet local and international regulatory requirements, coordinate updates, and manage cross-functional input from regulatory, legal, and marketing teams. Their work is crucial for ensuring accurate product information and supporting product approvals worldwide.

How does a global labeling manager coordinate with cross-functional teams to ensure timely product label approvals?

A Global Labeling Manager works closely with regulatory affairs, quality assurance, marketing, and R&D teams to develop and review product labels that comply with international regulations. Coordination involves regular meetings, clear communication of regulatory requirements, and tracking progress to ensure all stakeholders provide input and approvals within tight deadlines. Effective project management and collaboration skills are essential, as the role often manages multiple product submissions across various markets simultaneously.

What are the key skills and qualifications needed to thrive as a global labeling manager, and why are they important?

To thrive as a Global Labeling Manager, you need expertise in regulatory affairs, knowledge of international labeling requirements, and a degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are often required. Strong project management, attention to detail, and cross-cultural communication skills help navigate complex global teams and ensure compliance. These competencies are crucial to ensure accurate, timely labeling that meets global regulatory standards and supports product safety and market access.

What is the difference between Global Labeling Manager vs Regulatory Labeling Specialist?

AspectGlobal Labeling ManagerRegulatory Labeling Specialist
CredentialsBachelor's degree in life sciences, regulatory affairs, or related field; often requires experience in labeling and complianceBachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are common
Work EnvironmentGlobal pharmaceutical or biotech companies, overseeing labeling across multiple regionsRegulatory departments within pharmaceutical companies, focusing on specific products or regions
Industry UsageUsed in large organizations managing global product labeling strategiesCommon in regulatory teams ensuring compliance for specific markets or products

The Global Labeling Manager oversees worldwide labeling strategies, ensuring compliance across regions, while the Regulatory Labeling Specialist focuses on detailed regulatory labeling for specific products or markets. Both roles require regulatory knowledge but differ in scope and responsibility.

What cities in Indiana are hiring for Global Labeling Manager jobs?

Cities in Indiana with the most Global Labeling Manager job openings:

Infographic showing various Global Labeling Manager job openings in Indiana as of August 2026, with employment types broken down into 85% Full Time, 13% Part Time, and 2% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution.

Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine

Indianapolis, IN • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 12 days ago

Job description

About The Role

As the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies—from portfolio entry through end of life. You will provide strategic and technical leadership to a cross-functional Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.

Key Responsibilities
  • Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle
  • Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice
  • Lead regulatory representation on the GBD/global program team; shape development plans and address regulatory barriers
  • Ensure local affiliate regulatory plans align to global strategy and business priorities (labeling, risk management, issues management)
  • Oversee US FDA submissions and agency interactions (INDs, NDAs, BLAs)
  • Drive high-quality communications with FDA articulating scientific position
  • Build relationships with FDA to support product registration goals
  • Provide strategic direction to a cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling)
  • Foster transparent communication, feedback, and continuous development
  • Represent GRA at stakeholder/governance meetings; mentor GRA personnel
  • Build external stakeholder relationships; advise promotional strategy and review press/IR materials
Minimum Qualifications
  • Advanced scientific degree (PharmD, PhD) and 8+ years in regulatory affairs and/or drug development
  • OR
  • Bachelor’s or Masters and 10+ years in regulatory affairs and/or drug development
Additional Preferences
  • Global regulatory procedures knowledge; experience across US, EU, China, Japan
  • Clinical and CMC regulatory science experience
  • Leadership, negotiation, and executive-level communication skills
  • Risk assessment/management experience; therapeutic area experience
Additional Information
  • Travel: 10–15%
Benefits (as stated)
  • Eligibility for company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
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