Remote Global Regulatory Labeling Strategist

Parexel; Tallahassee (FL); On-site; USD 130,000 - 190,000; Full time

Job summary

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to shape global labeling strategy across a diverse portfolio. You will own TPL development, CCDS governance, and regulatory submissions from early development through lifecycle management, interfacing with Regulatory, Clinical, Safety, Medical, and Commercial teams.

You will guide ROW labeling assessments, lead governance committees, and ensure high‑quality, compliant labeling documentation across markets.

Qualifications

• Bachelor’s degree in Life Sciences or related field required; MSc/PhD/PharmD preferred.
• 7–10+ years in biotech/pharma with 5–7+ years global labeling/regulatory leadership.
• Experience leading cross-functional teams and influencing stakeholders in global settings.

Responsibilities

• Provide global labeling strategy across CCDS, US, EU, ROW, and major markets.
• Lead TPL development for early-stage assets and CCDS ownership.
• Develop labeling content for regulatory submissions (MAAs) and amendments.
• Support ROW labeling assessments and Health Authority responses.
• Communicate strategy and risks to Global Regulatory Science leadership and partners.
• Coordinate end-to-end labeling processes and governance.

Skills

Leadership

Regulatory strategy

Global labeling

Medical writing

Cross-functional collaboration

Project management

Communication

Education

Bachelor's degree in Life Sciences

Advanced degree (MSc, PhD, PharmD) preferred

Tools

RIMS (Veeva)

eDMS (Veeva)

TrackWise

Job description

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to shape global labeling strategy across a diverse portfolio. You will own TPL development, CCDS governance, and regulatory submissions from early development through lifecycle management, interfacing with Regulatory, Clinical, Safety, Medical, and Commercial teams.

You will guide ROW labeling assessments, lead governance committees, and ensure high‑quality, compliant labeling documentation across markets.