Senior / Global Regulatory Labeling Strategist

Parexel•Southport, NC

About The Position

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to provide strategic leadership and operational oversight for global labeling across a portfolio of innovative therapies. The role spans early development through post-approval lifecycle management and includes work at the intersection of regulatory strategy, scientific communication, and product development. The strategist will own Target Product Label (TPL) development for early-stage assets and support Company Core Data Sheets (CCDS), regional labeling strategies, health authority responses, and labeling for major regulatory applications. The position also contributes to medical and technical writing, Rest of World (ROW) impact assessments, and cross-functional decisions affecting global product development and commercialization. As a member of the regulatory team, the strategist will define labeling strategy, lead governance committees and team meetings, and collaborate with global Regulatory, Clinical, Safety, Medical, Commercial, affiliate, and third-party stakeholders. The role is responsible for delivering compliant, high-quality labeling documentation and communicating strategy, risks, mitigation plans, and regulatory requirements throughout the product lifecycle. Candidates in the U.S. Eastern time zone are strongly preferred; candidates in other U.S. time zones may be considered if they can provide coverage during Eastern time hours.

Requirements

Bachelor’s degree in Life Sciences or a related field.
7–10+ years of experience in the biotech or pharmaceutical industry.
5–7+ years of global labeling or regulatory experience with global strategic leadership responsibilities.
Direct experience authoring, maintaining, and governing CCDS, including ownership of global labeling updates and coordination of downstream implementation across regional labels.
Experience delivering labeling for at least one major application, such as NDA, BLA, MAA, or JNDA.
Strong experience with CTD format and content for regulatory filings.
Strong knowledge of current global regulations, including vaccine development regulations and registration pathways.
Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings.
Experience facilitating meetings and driving consensus and results.
Proven medical and technical writing ability.
Excellent written and oral communication, leadership, and collaboration skills.
Ability to respond with urgency to FDA, EMA, MHRA, and other health authority communications and timelines, including providing coverage for product approvals and labeling negotiations.
Ability to work effectively in global, cross-cultural, matrix environments and build strong working relationships.
Ability to link company and departmental visions with daily work, adapt to varied situations, and maintain integrity and high standards.
Demonstrated problem-solving ability, risk analysis, and sound decision-making, with strong organizational skills and attention to detail.
Proficient regulatory knowledge, including scientific concepts in labeling and their global implications.
Fluency in written and spoken English.
Familiarity 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.

Nice To Haves

Advanced degree such as an MSc, PhD, or PharmD.
Labeling experience in rare diseases, oncology, and/or vaccines.
Experience with TPL work for early development programs and identified lifecycle programs.
Previous experience in oncology or rare disease.
Additional languages.
Location in the U.S. Eastern time zone; alternatively, flexibility to provide coverage during Eastern time hours.

Responsibilities

Provide global labeling strategy support across CCDS, U.S., EU, ROW, and other major markets.
Develop and maintain knowledge of labeling regulations and industry standards, and communicate requirements to stakeholders.
Lead Target Product Label (TPL) development for early-phase assets.
Develop labeling content, format, and accountability for regulatory submissions, including MAAs, supplements, and amendments, ensuring new labeling text meets regulatory requirements.
Support project teams with ROW labeling assessments against the CCDS and preparation of health authority responses.
Work with project teams to ensure labeling-process consistency and local compliance with the CCDS.
Communicate regulatory labeling strategy, risks, mitigation strategies, and plans to the Global Regulatory Science Leadership Team, Project Development Teams, and senior management as relevant.
Provide input into the end-to-end labeling process.
Lead and manage labeling team meetings, drive strategic discussions, and manage content.
Provide coverage for other products during peak periods or team-member absences as needed.
Author, maintain, and govern CCDS, including global labeling updates and coordination of downstream implementation across regional labels.
Collaborate with regulatory sub-teams, the Global Labeling Committee, business partners, affiliates, and third parties.