Global Regulatory Labeling Lead, Associate Director

ProKatchers LLC; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

ProKatchers LLC in Cambridge, MA seeks an Associate Director, Global Regulatory Affairs Labeling Lead for a 6-month term to shape global labeling strategy for plasma-derived therapies, including CCDS, USPI, and EU SmPC.

The role partners with Regulatory, Clinical, Pharmacovigilance, Medical, Legal and Commercial teams to deliver compliant labeling plans, interpret US/EU requirements, and guide cross-functional labeling teams through submission timelines and governance.

Qualifications

• Experience in regulatory labeling strategy is a plus.
• Ability to lead cross-functional teams and manage timelines.
• Strong knowledge of US and EU labeling requirements.

Responsibilities

• Leads global regulatory labeling strategy for plasma-derived therapies, including CCDS, USPI, and EU SmPC.
• Partners with Regulatory, Clinical, Pharmacovigilance, Medical, Legal, and Commercial teams to develop labeling plans.
• Interprets scientific and regulatory data to ensure compliant labeling for US/EU markets and health authority guidance.
• Leads cross-functional labeling teams, manages submission timelines and governance, ensuring QC and version control.

Job description

ProKatchers LLC in Cambridge, MA seeks an Associate Director, Global Regulatory Affairs Labeling Lead for a 6-month term to shape global labeling strategy for plasma-derived therapies, including CCDS, USPI, and EU SmPC.

The role partners with Regulatory, Clinical, Pharmacovigilance, Medical, Legal and Commercial teams to deliver compliant labeling plans, interpret US/EU requirements, and guide cross-functional labeling teams through submission timelines and governance.