Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist
Employment type
Full-time
Work setting
On-site
Location
Helena, MT
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Consultant is an onsite role based in Helena, MT, providing strategic leadership for global labeling initiatives at Parexel. Compensation is not specified for this position, which requires 5-7 years of biotech/pharmaceutical experience. This role exists to define and drive global labeling strategy, ensuring innovative products are supported by clear, compliant documentation. The strategist chairs governance committees and collaborates cross-functionally to manage labeling content throughout the product lifecycle.
What you'll do
- Define global labeling strategy for foundational and non-foundational markets.
- Chair Labeling Review Committees.
- Oversee operational labeling activities and FDA submissions.
- Manage labeling for post-marketing and advertising compliance.
What we're looking for
- Skills & competencies
- full-timeday shifthelena mtregulatory affairslabelingstrategybiotechpharmaparexelno on-callno travel
- Work arrangement
- Weekend coverage required
Benefits & perks
- Standard Parexel benefits package.
Why this role
Strategic leadership role; focuses on global labeling governance.
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
- 11-9199.01
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Listing ID: d6c13798-aba6-43f2-acf4-4adb4fb74bed