Regulatory Affairs Associate I

Planet Pharma; North Chicago (IL); On-site; USD 28,000 - 41,000; Full time

Job summary

Planet Pharma is seeking a Regulatory Information Management support professional in Illinois. The role focuses on regional regulatory submissions, system-based data stewardship, and ensuring alignment with central data standards.

Fresh graduates with relevant life sciences backgrounds are encouraged to apply, with an emphasis on strong communication skills. Responsibilities include managing registrations, dates, and correspondences across COSMOS and CIU, plus collaboration with analytics teams

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, medical technology or pharmacology) required.
• Fresh graduates with pharmacy/health sciences background considered.
• Strong written and verbal communication skills.

Responsibilities

• Support regulatory information management activities in the region focusing on COSMOS, HUBBLE and CIU.
• Create or update product registrations to align with approvals or renewals.
• Collaborate with central data management to ensure accurate tracking of regulatory submissions in the region.
• Monitor Cosmos to record submission and approval dates and ensure archiving where needed.
• Work with regional data leads and Analytics to develop KPIs in Hubble and related systems.

Skills

Communication skills

Education

Bachelor's degree in life sciences

Job description

Target PR Range: 20-30/hr

• Depending on experience

Responsibilities May Include

• Uses knowledge of planned submissions and approvals in a region to:
• Supports regulatory information management activities in the region focusing on key systems and processes, including COSMOS, HUBBLE and CIU
• Connect with central data management team and following agreed upon data standards, proactively create market-specific RIM Objects.
• Create or Update product registration to align with approval or renewal (e.g. new registration, new validity date period, new indication, new pack)
• Commitment/Obligation recording and updating
• Bridge local regulatory processes with COSMOS activity framework to ensure accurate and complete tracking of all regulatory submissions and correspondences in the region, keeping alignment across countries and regions by liaising with other regional data leads to enabling accurate reporting
• Proactively monitor Cosmos to
• Ensure submission dates, approval dates are recorded in Cosmos (structure and activity if first submission under the activity); may include follow-up with affiliate about distributor submission dates
• Monitor that submission has been archived via CIU
• Move activity to a completed status if a notification only activity
• Monitor that Correspondence/responses from agency are imported into Cosmos in association with relevant activity
• Response structures linked to relevant activity
• Approval letter imported in relation to relevant activity; Activity status and date updated to reflect approval
• Support Audit/Inspection requests in region related to submissions, commitments, correspondences and approval data in CosmosCollaborate with central team for monthly QC reports, identify gaps and support data remediation activities.
• Capture requirements for relevant KPIs/metrics according to regional needs, and liaise with other regional data leads and Analytics team to develop advanced analytics capabilities in the Hubble
• Support adoption of system enhancements and new functionalities.
• Support migration and harmonization of data during system upgrades and process improvements.

Qualifications

• Required Education: Bachelor's degree in related life sciences (pharmacy, biology, chemistry, medical technology pharmacology)
• Required Experience: Fresh graduate with pharmacy / health sciences background
• Good communication, both oral and written