Associate Principal Scientist, Regulatory Liaison
Core
Develop and implement global regulatory strategies for Vaccine and Infectious Disease products, managing submissions and agency communications.
Role type
Associate Principal Scientist, Regulatory Liaison
Builds
Global regulatory strategy documents, marketing applications, INDs, and agency response packages for VID products.
Domain
Pharmaceutical industry, Vaccine and Infectious Disease therapeutic area
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, Regulatory submissions, Agency communications, Competitive intelligence, Life cycle planning, Cross-functional collaboration, Scientific analysis, Process improvement
Preferred skills
Drug development experience, Anti-infectives and/or vaccine product knowledge
Technologies
Regulatory guidelines, Agency databases, Submission platforms
Responsibilities
Assist in preparing and shepherding regulatory submissions (marketing applications, INDs, periodic reports); Communicate with agencies and attend meetings to support the Global Liaison; Conduct research on regulatory guidance and competitive intelligence; Collaborate with Clinical Safety, Labeling, and CMC teams on regulatory strategy; Support label development and quality compliance maintenance.
Seniority
Senior, hands-on IC