KH
Regulatory Affairs Associate
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Hybrid
Entry level
3 months ago
- Veeva
3 months ago
Not enough detail in this posting to match
- Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU
- Create and maintain regulatory records, including:
- Product registrations
- Approval and renewal updates
- Indication and packaging changes
- Commitment and obligation tracking
- Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
- Monitor submission and approval activities to maintain data integrity and compliance.
- Support audit and inspection requests related to regulatory submissions and approvals.
- Participate in monthly quality control reviews, identify data gaps, and support remediation efforts.
- Assist with system enhancements, upgrades, and continuous process improvement initiatives.
- Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline
- Experience or exposure to Regulatory Data Management
- Familiarity with Veeva systems
- Strong written and verbal communication skills
- High attention to detail and an interest in global regulatory processes
- Why This Opportunity Stands Out
- Whether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment.
- Interested or know someone who would be a great fit? Reach out today.
Regulatory Affairs Associate · Katalyst Healthcares & Life Sciences