Senior Regulatory Affairs Consultant Labeling

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Parexel is seeking an experienced Global Regulatory Labeling Manager to collaborate with a dedicated client team and oversee complex global labeling initiatives.

In this role you will lead and coordinate labeling activities across foundational and non-foundational markets ensuring compliance with global regulatory requirements and supporting product lifecycle management. You will play a critical role in maintaining label governance managing committees and supporting advertising and promotional material reviews.

Key Responsibilities:

Label Updates & Governance

Prepare administrative label updates for multiple markets (EU US AU CH DE).

Coordinate and manage EU administrative updates (e.g. address changes Windsor updates).

Develop manage and track governance for company positions (DLS CCDS USPI and EU SmPC) and foundational markets.

Maintain multi-market manuscripts and dependent market lists.

Provide strategic input to therapeutic area teams and influence external labeling landscape.

Compliance & Documentation:

Prepare deviation documentation for non-foundational markets (DTT).

Manage GRA label compliance processes including QC and oversight of labeling performance.

Maintain FDA-508 compliance on US labels.

Prepare and manage change control documentation for foundational markets.

Manage specimen requests and verify part numbers for correct labeling submissions.

Committee & Cross-Functional Leadership:

Prepare documents for Labeling Review Committee (LRC) and run LRC meetings.

Prepare Global Labeling Committee (GLC) materials for endorsement and implement GLC decisions.

Prepare documents for CCDS Working Team and run working Team sessions.

Regulatory Submissions & Negotiations

Support label negotiations for foundational and other markets.

Prepare differences tracking tables against CCDS or reference markets.

Manage and track labeling HA requests and responses.

Prepare RFIs and manage HA negotiations.

Advertising & Promotion:

Review and approve direct-to-consumer and marketing advertising medical education and social media content.

Participate in promotional review committees providing regulatory guidance aligned with local requirements.

Artwork & Safety Reporting:

Manage and proofread artwork for foundational markets TOLL PAHO and ASUs.

Prepare review and approve mock-ups and artwork for production including combination products/devices.

Prepare labeling documents for safety reports (PSUR PBER) and CH safety reports.

Special Projects:

Prepare annual strain updates for Northern and Southern Hemisphere flu campaigns.

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

Qualifications:

Education:

University degree (4-year) in Life Sciences or related Pharmaceutical field (e.g. Chemistry Engineering).

Advanced degree (MSc PhD PharmD) preferred.

Experience:

Minimum of 5-7 years in the biotech/pharmaceutical industry.

At least 2 years of labeling/regulatory experience with global responsibilities.

Proven experience leading teams in a matrix organization.

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

Experience in flu campaigns and pandemic products.

Experience with direct-to-consumer and marketing advertising educational materials and social media.

Technical Systems Expertise:

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.

Core Competencies:

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); additional languages would be an asset.

Why Join Us

This is an opportunity to make a global impact in regulatory affairs ensuring patients worldwide receive accurate and compliant product information. You will work across diverse markets lead critical governance processes and contribute to innovative campaigns in a dynamic collaborative environment.

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