[Hiring] Senior Global Regulatory Labeling Strategist @Parexel

Role Description

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
• 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
• 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.

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
• 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
• 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

Requirements

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

Benefits

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.