Associate Director Global Regulatory Affairs

Apolis; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Apolis is seeking an experienced Associate Director, Global Regulatory Affairs (Labeling Lead) to guide global labeling strategy for plasma-derived therapies. Based in Cambridge, MA, you will work with Clinical, Pharmacovigilance, Medical Affairs, Legal, Regulatory, and Commercial teams to shape labeling for products and devices across markets.

The role requires leading cross-functional teams, interpreting scientific data, and ensuring compliance with US/EU labeling regulations, including CCDS,

Qualifications

• 7–10+ years in biopharmaceutical/pharmaceutical industry.
• 5–7+ years in global, US, or EU labeling.
• Strong expertise in Regulatory Affairs – Labeling.
• Experience with CCDS (Core Data Sheet), USPI, EU SmPC.
• Knowledge of US/EU labeling regulations and guidance.
• Experience with SPL requirements (PLR labeling).
• Experience with drug-device labeling.
• Experience with EDMS and labeling tracking systems.
• Excellent stakeholder management, communication, and influencing skills.
• Ability to lead global, cross-functional teams.

Responsibilities

• Lead global labeling strategy and lifecycle management for CCDS, USPI, and EU SmPC.
• Develop and implement regulatory labeling strategies for development, commercialization, and global expansion.
• Lead global labeling teams and cross-functional labeling projects.
• Interpret scientific, clinical, medical, and regulatory data to develop labeling strategies.
• Provide guidance on US and EU labeling requirements and Health Authority expectations.
• Support labeling for combination product/drug-device strategies.
• Develop labeling for new products and manage updates throughout lifecycle.
• Incorporate Health Authority feedback and regulatory guidance into strategies.
• Lead cross-functional discussions and drive consensus among stakeholders.
• Prepare submission-ready labeling components and support Health Authority interactions.
• Ensure document control, version control, QC, tracking, and archiving.
• Partner with Regulatory Intelligence to assess labeling regulation changes.
• Develop and deliver regulatory labeling training programs.
• Identify process and system improvements to enhance labeling quality and efficiency.

Skills

Regulatory labeling

US/EU labeling regs

Stakeholder mgmt

Cross-functional leadership

Strategic thinking

EDMS

Documentation control

Leadership

Education

Advanced degree in science/health

Tools

EDMS systems

Job description

Job Title: Associate Director

Location: Cambridge MA

Duration: Long Term

Industry: Biopharmaceutical / Pharmaceutical Hybrid position

Job Summary

We are seeking an experienced Associate Director, Global Regulatory Affairs (RA) Labeling Lead to join the Plasma-Derived Therapies (PDT) organization at a leading global biopharmaceutical company. This role will lead global regulatory labeling strategy and lifecycle management for pharmaceutical drug and device products, working closely with Clinical, Pharmacovigilance, Medical Affairs, Legal, Commercial, Regulatory, and other cross-functional teams.

Key Responsibilities

• Lead global labeling strategy and lifecycle management for CCDS, USPI, and EU SmPC.
• Develop and implement regulatory labeling strategies supporting product development, commercialization, and global expansion.
• Lead global labeling teams and cross-functional labeling projects.
• Interpret scientific, clinical, medical, and regulatory data to develop effective labeling strategies.
• Provide strategic guidance on US and EU labeling requirements and Health Authority expectations.
• Support combination product/drug-device labeling strategies.
• Develop labeling for new products and manage updates throughout the product lifecycle.
• Incorporate Health Authority feedback, regulatory precedent, and guidance into labeling strategies.
• Lead cross-functional discussions and drive consensus among global stakeholders.
• Prepare submission-ready labeling components and support Health Authority interactions.
• Ensure appropriate document control, version control, QC, tracking, and archival of labeling documentation.
• Partner with Regulatory Intelligence teams to assess changes in labeling regulations and their impact on products.
• Develop and deliver regulatory labeling training programs.
• Identify process and system improvements to enhance labeling quality, compliance, and efficiency.

Required Qualifications & Skills

• 7–10+ years of experience in the biopharmaceutical/pharmaceutical industry.
• 5–7+ years of direct experience in global, US, or EU regulatory labeling preferred.
• Strong expertise in Regulatory Affairs – Labeling.
• Hands-on experience developing and maintaining:
• Company Core Data Sheet (CCDS)
• US Prescribing Information (USPI)
• EU Summary of Product Characteristics (SmPC)
• Strong understanding of US and EU pharmaceutical labeling regulations and guidance.
• Experience with SPL (Structured Product Labeling) requirements, including legacy and PLR labeling.
• Experience with drug-device/combination product labeling preferred.
• Strong understanding of pharmaceutical drug and device development.
• Experience working with Electronic Document Management Systems (EDMS) and end-to-end labeling tracking systems.
• Excellent stakeholder management, communication, strategic thinking, and influencing skills.
• Ability to lead global, cross-functional teams and influence senior stakeholders without direct authority.

Preferred Qualifications

• Experience with plasma-derived therapies (PDT) and/or biologics.
• Experience in advertising and promotion regulations.
• Advanced degree in a scientific or health-related discipline.
• Previous people leadership or direct management experience.
• Experience working across global markets, particularly US, EU, and international regulatory environments.

apolis2024