Senior​/Global Regulatory Labeling Strategist

Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets?

Parexel is seeking an experienced and highly motivated Senior/ G
lobal Regulatory Labeling Strategist to play a pivotal role in shaping global labeling strategy across a diverse portfolio of innovative therapies. This highly visible position offers the opportunity to lead complex labeling initiatives from early development through post-approval lifecycle management, working at the intersection of regulatory strategy, scientific communication, and product development.

In this role, you will provide strategic leadership and operational oversight for global labeling activities, including hands-on ownership of Target Product Label (TPL) development for early-stage assets, Company Core Data Sheets (CCDS), regional labeling strategies, health authority responses, and labeling support for major regulatory applications. You will also contribute to medical and technical writing activities, ROW impact assessments, and cross-functional decision-making that influences product development and commercialization globally.

As a key member of the regulatory team, you will define labeling strategy, lead governance committees, partner with global stakeholders across Regulatory, Clinical, Safety, Medical, and Commercial functions, and ensure the delivery of compliant, high-quality labeling documentation throughout the product lifecycle.

This is an exceptional opportunity for a labeling professional who wants to make a meaningful impact on global regulatory strategy, influence product development decisions, and work across a broad range of products, therapeutic areas, and international markets.

• 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.

• 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.

• Bachelor's degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred.

• 7-10+ years…