Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist
Employment type
Full-time
Work setting
On-site
Location
Annapolis, MD
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist is an onsite role based in Annapolis, MD. Compensation is not specified for this position, which supports global labeling initiatives. This role provides strategic leadership and operational oversight for complex global labeling initiatives. The strategist will define labeling strategy, lead governance committees, and collaborate cross-functionally to deliver compliant, high-quality documentation throughout the product lifecycle.
What you'll do
- Define and drive global labeling strategy.
- Lead creation and management of core labeling documents (CDS, USPI, EU SmPC).
- Chair and manage Labeling Review Committees.
- Oversee operational labeling activities and artwork coordination.
- Partner with regional leads to address Health Authority inquiries.
What we're looking for
- Skills & competencies
- full-timeday shiftannapolis mdregulatory affairslabelingglobal strategybiotechpharmaceuticalcompliancegovernance
- Work arrangement
- Weekend coverage required
Benefits & perks
- Competitive benefits package.
Why this role
Requires 5-7 years of experience in the biotech/pharmaceutical industry and 2+ years in global labeling/regulatory 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: ba088636-4dbc-4e64-8eb1-9a5053a63021