Remote Global Regulatory Labeling Strategist

Parexel; Austin (TX); Remote; USD 160,000 - 230,000; Full time

Job summary

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling initiatives across multiple markets and product lifecycle. You will own TPL development for early assets, CCDS governance, and cross-functional collaboration with Regulatory, Clinical, Safety, Medical, and Commercial teams to shape compliant labeling strategies worldwide.

This role offers visibility, impact, and partnership with senior leadership to ensure labeling excellence across regulatory

Qualifications

• Experience facilitating meetings and driving consensus and results.
• Excellent leadership, communication (verbal and written) and collaboration skills.
• Proven ability in medical/technical writing.
• Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable.
• Experience with TPL work for early development programs and identified life-cycle programs.
• Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.
• Integrity: overriding commitment to integrity and high standards for self and others.
• Results orientation
• Strategic orientation: ability to link company and departmental visions with daily work
• Interact effectively as a member of the Regulatory sub-team, communicating effectively on strategies to the Global Labeling Committee and collaborating with business partners, including affiliates and third parties.
• Flexibility/adaptability: ability to adapt to, and work effectively within, a variety of situations and with various individuals and groups.
• Relationship building, teamwork and cooperation: builds and maintains strong working relationships with colleagues.

Responsibilities

• Global labeling experience to provide labeling strategy support across labeling for CCDS, US, EU, Rest of World (ROW), and other major markets.
• Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
• Lead the TPL development for early-phase assets.
• Develop labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
• Support the project teams with Rest of World ROW labeling assessments against the CCDS and preparation of Health Authority (HA) responses.
• Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
• Effectively communicate the regulatory labeling strategy, risks, mitigation strategies and overall plans to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant.
• Provide input for the end-to-end labeling process.
• Ability to lead and manage labeling team meetings, driving strategic discussions and managing content.
• Provide coverage, as needed, on other products during peak periods or during absences of other team members.

Skills

Global labeling

Leadership

Medical writing

Regulatory strategy

CTD knowledge

Regulatory timelines

Cross-functional collaboration

Stakeholder management

Attention to detail

Education

Bachelor’s degree in Life Sciences

MSc/PhD/PharmD preferred

Tools

Veeva RIMS

eDMS (Veeva)

Trackwise

Microsoft Office

SharePoint

Job description

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling initiatives across multiple markets and product lifecycle. You will own TPL development for early assets, CCDS governance, and cross-functional collaboration with Regulatory, Clinical, Safety, Medical, and Commercial teams to shape compliant labeling strategies worldwide.

This role offers visibility, impact, and partnership with senior leadership to ensure labeling excellence across regulatory