Senior / Global Regulatory Labeling Strategist

Parexel; Austin (TX); A distancia; USD 160.000 - 230.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Global labeling

Leadership

Medical writing

Regulatory strategy

CTD knowledge

Regulatory timelines

Cross-functional collaboration

Stakeholder management

Attention to detail

Educación

Bachelor’s degree in Life Sciences

MSc/PhD/PharmD preferred

Herramientas

Veeva RIMS

eDMS (Veeva)

Trackwise

Microsoft Office

SharePoint

Descripción del empleo

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/Global 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.

Key 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.

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.

Education

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

Experience

• 7-10+ years in biotech/pharmaceutical industry; 5-7+ 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 current global regulations, including specifically: e.g. vaccine development regulations and registrations pathways.




• Previous experience in oncology or rare disease is highly preferred




• Strong experience with CTD format and content regulatory filings




• Direct experience authoring, maintaining, and governing CCDS is required, including ownership of global labeling updates and coordination of downstream implementation across regional labels.




• Exceptional written and oral communication




• Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.)

Technical Expertise

• Must be familiar with 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 global regulatory requirements relevant to drug development, global labeling, and post‑marketing




• 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.

While candidates located in the EST time zone are strongly preferred, candidates in other U.S. time zones who have the flexibility to provide coverage during EST hours will also be considered.

Why Join Us

This is an opportunity to shape global labeling strategy, lead governance processes, and ensure patients worldwide receive accurate and compliant product information. You will work across diverse markets, influence external landscapes, and contribute to innovative campaigns in a dynamic, collaborative environment.

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.