Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist
Employment type
Full-time
Work setting
On-site
Location
Indianapolis, IN
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist is an onsite role based in Indianapolis, IN. Compensation is not specified for this position, which supports global labeling initiatives for life-changing therapies. This role exists to provide strategic leadership for global labeling content, ensuring products are supported by compliant documentation. It contributes to the company's goals by managing the labeling lifecycle across international markets and facilitating health authority engagements.
What you'll do
- Define global labeling strategy.
- Lead Labeling Review Committees.
- Manage core labeling documents including CDS, USPI, and EU SmPC.
- Oversee operational labeling activities and ensure FDA Section 508 compliance.
What we're looking for
- Skills & competencies
- full-timeday shiftindianapolis inparexelregulatory affairslabelingglobal strategycompliancebiotechonsite
- Work arrangement
- Weekend coverage required
Why this role
Requires 5-7 years of biotech/pharma experience with specific focus on global labeling strategy.
About the employer
Parexel is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.
Additional details
- Industry sector
- 54
- Industry
- Administrative Management and General Management Consulting Services
- Occupation code
- 11-9199.02
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Listing ID: d935e370-bea1-41bc-bce5-a0555618582e