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Parexel · 3 days ago

Regulatory Affairs Consultant - Labeling Operations

United States

Full-time

Remote

Senior Level

5+ years exp

Parexel is seeking a Global Labeling Operations Manager to oversee end-to-end labeling operations across multiple markets. The role involves ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate and timely labeling updates.

Pharmaceuticals

H1B Sponsor Likely

Hiring Manager

Lisa B.

Responsibilities

Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership

Coordinate readability testing (planning, team review, and communications)

Oversee translations for foundational markets (EU, CH, DE)

Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL)

Upload approved labels to internal systems (Documentum, Weblabel, intranet)

Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders

Lead impact assessments for technical and global labeling changes across dependent markets

Perform data entry in Trackwise/Veeva and prepare annual labeling reports

Review and update submission content plans; prepare change control documentation for CCDS-driven changes

Prepare and manage Structured Product Labeling (SPL)

Support advertising and promotional and marketing material reviews, educational materials, and social media compliance

Ensure compliance with country-specific regulatory requirements

Act as key partner to GRA Regions, Regulatory CMC and Supply Chain

Qualification

Regulatory labeling managementBiotech/pharma experienceTeam leadershipRIMS familiarityMicrosoft Office proficiencyFluency in EnglishProblem-solving skillsEffective communicationOrganizational skills

Required

University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred

Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility

Experience leading teams in a matrix organization

Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management

Experience with flu campaigns, pandemic products, and direct-to-consumer advertising

Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems

Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS

Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing

Strong problem-solving skills with the ability to analyze risk and recommend solutions

Effective communicator, able to explain complex concepts and influence cross-functional colleagues

Excellent organizational skills with attention to detail and strategic thinking

Ability to thrive in complex, matrixed, and cross-cultural environments

Fluency in English (verbal and written); additional languages a plus

Preferred

Advanced degree (MSc, PhD, PharmD)

Benefits

Competitive compensation

Benefits

Opportunities for career growth

Company

Parexel

Glassdoor3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)