Associate Director, Global Labeling

Scorpion Therapeutics; Philadelphia (Philadelphia County); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics is seeking a Regulatory Labeling professional to lead global labeling efforts from Cambridge, MA or Philadelphia, PA. The role interfaces with Global Regulatory Teams and Core Labeling Teams to ensure CCDS accuracy and alignment with health authority requirements.

The candidate will draft prescribing information content, monitor regulatory changes, and coordinate labeling activities with internal and external partners to support submission readiness.

Qualifications

• BS/BA in science or related field (graduate degree desirable).
• Biopharmaceutical regulatory affairs, pharmacovigilance, and/or medical writing/communications experience.

Responsibilities

• Represent Global Labeling on product-specific Global Regulatory Teams and cross-functional teams.
• Create, revise, and maintain CCDS with Global Regulatory Leads and Core Labeling Teams.
• Develop labeling strategies and Target Label Profiles.
• Provide strategic guidance on labeling regulations, competitor labeling, and trends.
• Review and communicate impact of labeling legislation/guidelines.

Skills

Regulatory Affairs

Biopharma Experience

Labeling

Medical Writing/Communications

Detail-Oriented

Communication Skills

Regulatory Standards

Cross-Functional Collaboration

Education

BS/BA in science or related

Graduate degree desirable

Job description

Key Responsibilities

• Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams.
• Create, revise, and maintain Company Core Data Sheets (CCDS) for Alnylam’s products with Global Regulatory Leads and Core Labeling Teams (CLTs).
• Develop labeling strategies and Target Label Profiles.
• Provide strategic guidance on new/revised labeling regulations, competitor labeling, and labeling trends.
• Review and communicate impact of changes in health authority labeling legislation/guidelines.
• Lead regional labeling development/maintenance aligned with the CCDS and health authority requirements.
• Prepare responses to labeling-related queries from health authorities.
• Coordinate labeling activities (e.g., supplements, new labeling development) with internal/external alliance partners.
• Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements; assist with submissions as needed.
• Track data sources supporting labeling claims and document labeling history and reasons for local differences.
• Support growth of the Global Labeling function; design/build systems and processes.

Qualifications

• BS/BA (science or related preferred); graduate degree desirable.
• Biopharmaceutical industry experience in Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
• At least 2 years in a Labeling role within Regulatory Affairs, including drafting prescribing information content.
• Familiarity with US, EU, and global pharmaceutical labeling regulations/standards/guidance.
• Ability to stay current on emerging data, product safety, manufacturing changes, and post-marketing commitments affecting CCDS and regional/local labeling.
• Detail-oriented; able to multi-task and manage multiple projects.
• Skilled in written and verbal communication.

Hybrid role: Cambridge, MA or Philadelphia, PA