Associate Director, Global Regulatory Sciences - CMC

Scorpion Therapeutics; Princeton (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in Princeton, NJ seeks a GRS-CMC Associate Director responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions.

This role interfaces with Global Regulatory Sciences and development and supply teams, guiding global change management and coordinating CMC submissions across markets.

Qualifications

• Bachelor's degree required; 8+ years pharma/regulatory CMC in development and/or lifecycle management.
• Experience with cell therapy/biologics and/or small molecules preferred.
• Ability to lead teams with minimal supervision and coordinate global activities.

Responsibilities

• Represent and/or lead matrix teams for small molecules, biologics, combination/device, and cell therapy products from development through post-marketing commitments and relevant lifecycle management projects.
• Provide strategic regulatory guidance for marketing applications, clinical trial applications, and lifecycle changes.
• Independently manage and prioritize multiple complex projects.
• Interface with Health Authorities for CMC submissions/issues; resolve routine/complex issues.
• Interpret global regulations/guidance; identify regulatory opportunities/risks; provide CMC expertise to development teams.
• Provide input to mitigate drug supply issues.
• Communicate with project teams on technical items impacting submissions/strategy/success.
• Assess change controls; prepare and manage CMC submissions for all global markets ensuring completeness and timeliness.
• Utilize electronic systems for dossier creation/tracking; support CMC policies/procedures.
• Maintain regulatory compliance via timely/accurate data entry into the Regulatory Information Management system.
• Identify continuous improvement opportunities; participate/lead teams to assess and educate on global regulatory landscape.

Skills

CMC regulatory strategy

Regulatory submissions

Cross-functional leadership

Health Authority interface

Project management

Analytical/problem solving

Communication skills

Education

BA/BS in life sciences or related field

Job description

Position Summary

GRS-CMC Associate Director responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions for BMS products, including clinical trial applications, new marketing applications, HA responses/background packages (including participating/leading HA meetings), and/or post-approval submissions. Primary interface between Global Regulatory Sciences (GRS) and Global Product Development and Supply (GPS) or Cell Therapy Development Operations (CTDO). Assesses Manufacturing Change Controls for global impact and guides technical teams on global change management.

Duties/Responsibilities

• Represent and/or lead matrix teams for small molecules, biologics, combination/device, and cell therapy products from development through post-marketing commitments and relevant lifecycle management projects.
• Provide strategic regulatory guidance for marketing applications, clinical trial applications, and lifecycle changes.
• Independently manage and prioritize multiple complex projects.
• Interface with Health Authorities for CMC submissions/issues; resolve routine/complex issues.
• Interpret global regulations/guidance; identify regulatory opportunities/risks; provide CMC expertise to development teams.
• Provide input to mitigate drug supply issues.
• Communicate with project teams on technical items impacting submissions/strategy/success.
• Assess change controls; prepare and manage CMC submissions for all global markets ensuring completeness and timeliness.
• Utilize electronic systems for dossier creation/tracking; support CMC policies/procedures.
• Maintain regulatory compliance via timely/accurate data entry into the Regulatory Information Management system.
• Identify continuous improvement opportunities; participate/lead teams to assess and educate on global regulatory landscape.

Qualifications

• Minimum BA/BS.
• 8+ years pharmaceutical industry experience; prefer small molecules, biotechnology, or cell therapy; 5+ years CMC regulatory strategy.
• Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules/biologics/cell therapy during development and post-approval.
• Knowledge of pharmaceutical development (upstream/downstream, analytical methods, and relevant combinations such as biologic/device).
• Expertise in biological/cell therapy and/or small molecule modalities, drug development process, and analytical methods (as applicable).
• Ability to partner, lead teams, represent regulatory functions across project teams/alliances, innovate/analyze/solve problems with minimal supervision, manage project work, coordinate global activities, and interpret global regulations.
• Strong oral/written skills; proficient with electronic systems.
• Travel up to 5%.