Senior / Global Regulatory Labeling Strategist

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Overview

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team. Success Profile Do you have these soft skills and interpersonal traits to succeed at Parexel? Communicator Detail-oriented Problem-solver Relationship-builder Results-driven Strategic Back to nav About This Role 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. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Back to nav Share this job LinkedIn Facebook X Email Employee Insights How to describe Parexel culture in one word Insights from Parexel employees Watch Video Jo on diverse project work and team culture Jo Wang | Vice President, Technical Watch Video Kurt on colleagues and growth opportunities Kurt Brorson | Vice President, Technical Watch Video Back to nav Why Consultants work at Parexel Patient-led in everything we do We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects. Supportive and inclusive environment We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge. Opportunities for career growth We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth. Flexible work arrangements We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment. Diverse and global client exposure We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval. Learn from experts You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career. Back to nav Learn About Our Culture Back to nav Back to nav Inclusion at Parexel Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment. Learn More Benefits & Support At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture. Learn More Emerging Talent Opportunities Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind. Learn More