Regulatory Affairs Associate

Description:

• 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  • Monitor that submission has been archived via CIU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 Cosmos
• Collaborate 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.
• Onsite - Lake County - Hybrid (Tues, Wed, Thurs. onsite)

Qualifications:

• Bachelor's degree in related life sciences (pharmacy, biology, chemistry, medical technology pharmacology)
• Fresh graduate with pharmacy / health sciences background
• Good communication, both oral and written
• GxP-compliant systems
• Regulatory Affairs (RA) systems
• LIMS experience is valuable
• Cosmos and Hubble experience is a plus but not required
• Pharmaceutical and Medical device industry experience desired
• Quality Assurance (QA) & Regulatory Affairs (RA)
• Internship experience accepted
• Academic experience involving regulated documentation or data management

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.