Regulatory Specialist

at  Canadian Nuclear Laboratories

Whiteshell, MB, Canada -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate19 Jan, 2025Not Specified20 Oct, 2024N/AGood communication skillsNoNo
Add to Wishlist Apply All Jobs
Required Visa Status:
CitizenGC
US CitizenStudent Visa
H1BCPT
OPTH4 Spouse of H1B
GC Green Card
Employment Type:
Full TimePart Time
PermanentIndependent - 1099
Contract – W2C2H Independent
C2H W2Contract – Corp 2 Corp
Contract to Hire – Corp 2 Corp

Description:

Are you looking for a role that will challenge you?
Our Pinawa, Manitoba location is looking for a Regulatory Specialist. Can you see yourself supporting management, coordinating regulatory affairs activities within Canadian Nuclear Laboratories (CNL), preparing licensing documents, coordinating preparations for Canadian Nuclear Safety Commission (CNSC) hearings and meetings, and providing recommendations for licensing strategies based on knowledge of the regulations and project or program requirements? If you said yes, then apply today!

What will you be doing?

  • Supporting the Manager, WL Licensing & End-State by coordinating licensing activities across CNL.
  • Leading the preparation of the annual reports; reviewing other sites annual reports to ensure consistency.
  • Leading preparations for CNSC Commission hearings and meetings.
  • Maintaining a schedule of licensing activities for CNL and managing routine communications within a defined CNL licensing area.
  • Participating as a regulatory affairs representative in various meetings.
  • Providing regulatory assistance and guidance to CNL, especially, to the Designated Representatives of the licencee (DROLs), i.e., Program Authorities, Facility Authorities, and Safety and Control Area owners.
  • Leading and/or participating in facilities and programs in the preparations for inspection and inspections from a regulatory affairs perspective.
  • Assisting facilities and programs in compliance reviews to ensure they are meeting the requirements in the site licence.
  • Providing guidance on the interpretation of regulatory requirements, including licensing basis assessments.
  • Identifying potentially reportable events.
  • Determining classification of regulatory actions and commitments.
  • Tracking and managing regulatory commitments CNL within a defined licensing area.
  • Preparing and reviewing licensing correspondence, preliminary verbal and full unplanned event reports, presentations, responses to CNSC questions.
  • Supporting activities associated with the Regulatory Affairs Transformation Plan.
  • Producing and revising regulatory affairs process documentation and coordinating the production of this documentation.
  • Providing training to CNL personnel on the branch documentation.
  • Preparing licensing protocols, progress reports and other licensing submissions.
  • Reviewing and providing comments on CNSC issued regulatory documents.
  • Review CNSC regulatory documents in consideration of CNL licence requirements.
  • Coordinating with Industry peers and submitting comments to CNSC staff.
  • Other duties as assigned by your manager.

Responsibilities:

  • Supporting the Manager, WL Licensing & End-State by coordinating licensing activities across CNL.
  • Leading the preparation of the annual reports; reviewing other sites annual reports to ensure consistency.
  • Leading preparations for CNSC Commission hearings and meetings.
  • Maintaining a schedule of licensing activities for CNL and managing routine communications within a defined CNL licensing area.
  • Participating as a regulatory affairs representative in various meetings.
  • Providing regulatory assistance and guidance to CNL, especially, to the Designated Representatives of the licencee (DROLs), i.e., Program Authorities, Facility Authorities, and Safety and Control Area owners.
  • Leading and/or participating in facilities and programs in the preparations for inspection and inspections from a regulatory affairs perspective.
  • Assisting facilities and programs in compliance reviews to ensure they are meeting the requirements in the site licence.
  • Providing guidance on the interpretation of regulatory requirements, including licensing basis assessments.
  • Identifying potentially reportable events.
  • Determining classification of regulatory actions and commitments.
  • Tracking and managing regulatory commitments CNL within a defined licensing area.
  • Preparing and reviewing licensing correspondence, preliminary verbal and full unplanned event reports, presentations, responses to CNSC questions.
  • Supporting activities associated with the Regulatory Affairs Transformation Plan.
  • Producing and revising regulatory affairs process documentation and coordinating the production of this documentation.
  • Providing training to CNL personnel on the branch documentation.
  • Preparing licensing protocols, progress reports and other licensing submissions.
  • Reviewing and providing comments on CNSC issued regulatory documents.
  • Review CNSC regulatory documents in consideration of CNL licence requirements.
  • Coordinating with Industry peers and submitting comments to CNSC staff.
  • Other duties as assigned by your manager


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Engineering or science or equivalent from a university of recognized standing is required

Proficient

1

Whiteshell, MB, Canada