Highlights
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. 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.
Numbers & Facts
| Location | Cambridge, MA |
| Industry | Computer/IT Services |
| Salary | $1–$125 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.apolisrises.com/ |
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
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
Benefits
Paid Sick Days, Employee Referral Program, Employee Events, Retirement / Pension Plans
About Company
Since 1996, RJT has provided successful SAP, Oracle, and IT consulting solutions and staffing services to clients around the world. The new Apolis brings you the same personalized service fortified with a greater array of IT solutions, global expertise, and cost-management strategies.
We are a global IT consultancy that seamlessly integrates experts and leading-edge solutions into your organization so you can focus on what really matters.