CMC Regulatory Affairs Associate — First-Pass Submissions

Planet Pharma; North Chicago (IL); On-site; USD 39,000 - 52,000; Full time

Job summary

Planet Pharma seeks a Senior Associate, RA CMC to collaborate with internal and external partners to deliver regulatory submissions and lifecycle management. The role focuses on preparing CMC strategies for INDs/CTAs and amendments, managing content for submissions under supervision, and staying aligned with product development teams.

Requires a Bachelor’s degree in a related field, 4 years of pharma experience, and strong communication skills. CO/ NYC candidates might not be considered.

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• Advanced degree preferred.

Responsibilities

• Prepare CMC regulatory submissions and document management.
• Develop regulatory strategies to support first-pass approvals under supervision.
• Collaborate with internal and external partners for dossiers and regulatory queries.

Education

Bachelor's degree

Advanced degree

Job description

Planet Pharma seeks a Senior Associate, RA CMC to collaborate with internal and external partners to deliver regulatory submissions and lifecycle management. The role focuses on preparing CMC strategies for INDs/CTAs and amendments, managing content for submissions under supervision, and staying aligned with product development teams.

Requires a Bachelor’s degree in a related field, 4 years of pharma experience, and strong communication skills. CO/ NYC candidates might not be considered.