Regulatory Labeling Consultant

New

Skills

Project Management Risk Assessment

Parexel, a global leader in clinical research, is seeking a Regulatory Affairs Consultant specializing in labeling for a 6-month temporary collaboration with a major client. This pivotal role focuses on developing, reviewing, and ensuring the compliance of pharmaceutical product labeling in alignment with US regulatory requirements. The consultant will provide strategic guidance, drive labeling consistency, and contribute expert leadership to cross-functional regulatory teams.

Job Overview

6-month temporary contract with Parexel, partnering with a major pharmaceutical client.
Lead US labeling strategy and compliance for biopharmaceutical products.
Contribute to efficient, patient-centric clinical development processes across therapeutic areas.

Key Responsibilities

Develop and implement labeling strategies ensuring alignment with regulatory requirements and business objectives.
Ensure high-quality, compliant labeling documents and artwork in accordance with FDA regulations.
Provide strategic input on regulatory documents such as TPVP, TCLP, and CCDS.
Drive consistency and regulatory compliance across all product labeling activities.
Serve as a strategic leader in the US Labeling Review Committee (LRC).

Required Skills & Qualifications

Minimum 7 years of experience in Regulatory Affairs, with at least 5 years in regulatory labeling strategy.
Expertise in US pharmaceutical labeling laws, regulations, and guidance.
Experience with regulatory advertising and promotion review (minimum 2 years preferred).
Strong leadership, communication, and interpersonal skills.
Ability to manage multiple projects, prioritize deadlines, and strategically assess regulatory risk.
Demonstrated ability to work collaboratively and influence cross-functional teams.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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