Global Labeling Strategy Lead for Life-Changing Therapies

Parexel; Annapolis (MD); On-site; USD 150,000 - 210,000; Full time

Job summary

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies, from early development through lifecycle management. You will own TPL development, CCDS, and regional labeling strategies, coordinating with Regulatory, Clinical, Safety, Medical and Commercial teams to deliver compliant labeling documentation.

This role requires strong medical writing and regulatory leadership, with proven ability to drive

Qualifications

• 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 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; 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.)

Responsibilities

• Global labeling experience to provide labeling strategy support across CCDS, US, EU, ROW, and other major markets.
• Develop and maintain current knowledge of labeling regulations and industry standards 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 ROW labeling assessments against the CCDS and preparation of Health Authority responses.
• Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
• Communicate the regulatory labeling strategy, risks, mitigation strategies and overall plans to leadership and teams.
• Provide input for the end-to-end labeling process.
• Lead labeling team meetings and drive strategic discussions.
• Provide coverage, as needed, on other products during peak periods or absences of other team members.

Skills

Leadership

Communication

Medical/Technical writing

Labeling experience

Regulatory strategy

Cross-cultural collaboration

Strategic thinking

Education

Bachelor’s in Life Sciences

Advanced degree (MSc/PhD/PharmD)

Tools

RIMS (Veeva)

eDMS (Veeva)

Apollo

Docubridge

Trackwise

MS Office

SharePoint

Job description

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies, from early development through lifecycle management. You will own TPL development, CCDS, and regional labeling strategies, coordinating with Regulatory, Clinical, Safety, Medical and Commercial teams to deliver compliant labeling documentation.

This role requires strong medical writing and regulatory leadership, with proven ability to drive