Apply on Employer Site

Parexel · 3 days ago

Senior / Regulatory Affairs Consultant - Labeling

United States

Full-time

Remote

Senior Level

5+ years exp

Parexel is seeking an experienced and highly motivated Global Regulatory Labeling Lead to provide strategic leadership and operational oversight for complex global labeling initiatives. This role is integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use of products across international markets.

Pharmaceuticals

H1B Sponsor Likely

Hiring Manager

Lisa B.

Responsibilities

Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE)

Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile

Align labeling content and strategy across U.S., EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership

Interpret clinical and scientific data to inform labeling content and product claims; identify strategic risks and opportunities

Remain current with global labeling regulations and provide training to internal stakeholders

Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation

Develop and maintain governance frameworks for company positions (DLS, CCDS, USPI, EU SmPC) and foundational markets

Influence external labeling landscape through policy intelligence and strategic engagement

Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions

Maintain labeling documentation within eDMS and regulatory tracking platforms; ensure robust version control and SOP adherence for audit readiness

Manage change control documentation, specimen requests, and verify part numbers for correct submissions

Ensure FDA Section 508 accessibility compliance on U.S. labels

Support regional implementation of CDS updates and monitor compliance across markets

Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations

Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities

Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance

Manage and proofread artwork for foundational markets, TOLL, PAHO, and ASUs; oversee mock-ups and production for combination products/devices

Lead annual strain updates for Northern/Southern Hemisphere flu campaigns

Manage labeling for US Drug Listing Reports, including NDC assignments and annual reporting

Qualification

Global labeling strategyRegulatory labeling lifecycleRIMS expertiseCross-functional leadershipHealth Authority negotiationsProblem-solving abilityAttention to detailFluency in EnglishEffective communicationOrganizational skillsCollaboration skills

Required

Bachelor's degree in Life Sciences or related field

5-7 years in biotech/pharmaceutical industry

2+ years in global labeling/regulatory with global strategic leadership responsibilities

Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings

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

Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations

Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise)

Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS

Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred)

Demonstrated problem-solving ability with risk analysis and sound decision-making

Strong collaboration skills, with experience working in global, cross-cultural, matrix environments

Organizational skills to interact seamlessly both internally and externally on compliance matters

Proficient regulatory knowledge, including scientific concepts within labeling and their global implications

Effective communication skills for explaining concepts, options, and impacts

Attention to detail with the ability to think strategically

Fluency in English (verbal and written)

Preferred

advanced degree (MSc, PhD, PharmD)

candidates located in the EST time zone

additional languages would be an asset

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)