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Regulatory affairs Jobs in Markham, ON

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Last updated: 1 day ago
Lead Licensing Specialist

Lead Licensing Specialist

GE VernovaMarkham, Ontario, Canada
Full-time +1
The Canada Lead Licensing Specialist Regulatory Affairs based in Canada will complete various technical licensing work scopes in Canada including new reactor licensing for the BWRX-300 Advanced Nuc...Show moreLast updated: 3 days ago
  • Promoted
Legal Partner, R&D Transactions

Legal Partner, R&D Transactions

Astellas PharmaMarkham, York Region, CA
Full-time
At Astellas, we strive to become a cutting-edge, value-driven life science innovator.We focus on patients, pioneering innovation, and a collaborative culture to turn innovative science into VALUE f...Show moreLast updated: 1 day ago
Senior Director, Market Access & Government Affairs

Senior Director, Market Access & Government Affairs

Teva PharmaceuticalsToronto, Canada, Ontario, M1B2K9
Full-time
Senior Director, Market Access and Government Affairs.As a key member of the Canadian leadership team, the Senior Director of Market Access, Government Affairs, and Strategic Operations will lead t...Show moreLast updated: 30+ days ago
Pipeline Medical Manager, Oncology

Pipeline Medical Manager, Oncology

AbbVieMarkham, Ontario, Canada
Full-time
Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients lives. At AbbVie we conduct groundbreaking science on a global scale ...Show moreLast updated: 29 days ago
  • Promoted
Project Leader, Validation Support

Project Leader, Validation Support

Apotex Inc.Richmond Hill, York Region, CA
Full-time
Project Leader, Validation Support.Apotex is a Canadian-based global health company dedicated to improving access to affordable, innovative medicines and health products worldwide.Headquartered in ...Show moreLast updated: 1 day ago
Senior Consultant, Government and Stakeholder Relations

Senior Consultant, Government and Stakeholder Relations

ExtendicareMarkham, Ontario, Canada
Full-time
Reporting to the Senior Manager Government and Stakeholder Relations the.Senior Government Relations Consultant.Extendicares national Government Relations and broader Public Affairs team in buildin...Show moreLast updated: 12 days ago
  • Promoted
Sales and Operations Planning Manager

Sales and Operations Planning Manager

Pacific Smoke International Inc.Markham, York Region, CA
Full-time
Get AI-powered advice on this job and more exclusive features.S&OP (Sales and Operations Planning) Manager.Director of Manufacturing Supply Chain & Logistics. In a fast-paced and evolving industry, ...Show moreLast updated: 1 day ago
  • Promoted
Regulatory Senior Scientist

Regulatory Senior Scientist

Great Connections Employment ServicesMarkham, York Region, CA
Full-time
Our client is a leading manufacturer, marketer, and seller of quality skin care, makeup, fragrance, and hair care products. The client is seeking a Senior Regulatory Scientist to join their growing ...Show moreLast updated: 1 day ago
Director / Consultant, Regulatory Affairs

Director / Consultant, Regulatory Affairs

CencoraRemote, ON
Remote
Full-time
Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Cook MedicalWhitchurch-Stouffville, ON, CA
Full-time +1
This is an excellent opportunity to join a fast growing, well established medical device industry leader as a Regulatory Affairs Specialist. This position is currently a 6 month contract with the po...Show moreLast updated: 1 day ago
  • Promoted
Head of Human Resource & General Affairs

Head of Human Resource & General Affairs

Bureau Veritas North AmericaMarkham, York Region, CA
Full-time
Head of Human Resource & General Affairs.Our employees are ambitious and humble, believing in what they do and that our purpose is shaping a world of trust. This role leads the HR and general affair...Show moreLast updated: 1 day ago
Associate Director, Global Medical Channels Enablement

Associate Director, Global Medical Channels Enablement

Astellas Pharma Inc.Markham, ON
Full-time
Astellas Canada – Associate Director, Global Medical Channels Enablement.At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of ...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist in Bakery Food Manufacturer

Regulatory Affairs Specialist in Bakery Food Manufacturer

Great ConnectionsNorth York, ON
Permanent
Our client, a leading bakery food manufacturer in Etobicoke / Vaughan is looking for an passionate and skilled Regulatory Affairs Specialist to join their team. This position plays a critical role in ...Show moreLast updated: 30+ days ago
  • Promoted
Medical Affairs Specialist

Medical Affairs Specialist

Schroeder Ambulatory CentreRichmond Hill, ON, Canada
Full-time
Overview and Purpose of the Role.Reporting to the Manager, Medical Affairs, the Medical Affairs Specialist supports the administrative functions of the department, including assisting with physicia...Show moreLast updated: 27 days ago
  • Promoted
Associate Director, Regulatory Strategy and Submissions

Associate Director, Regulatory Strategy and Submissions

Everest Clinical ResearchMarkham, York Region, CA
Full-time
Associate Director, Regulatory Strategy and Submissions.Everest Clinical Research (Everest) is a full-service contract research organization (CRO) providing a broad range of clinical research servi...Show moreLast updated: 1 day ago
Associate Director, Global Medical Channels Enablement - Urgently Hiring!

Associate Director, Global Medical Channels Enablement - Urgently Hiring!

AstellasMarkham, ON, Canada
Full-time
Astellas Canada – Associate Director, Global Medical Channels Enablement.At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of ...Show moreLast updated: 30+ days ago
regulatory compliance officer

regulatory compliance officer

Hercules Moving CompanyNorth York, ON, CA
Permanent
Experience : 2 years to less than 3 years.Analyze and provide advice on the managerial methods and organization of an establishment. Develop quality management and quality assurance standards.Conduct...Show moreLast updated: 15 days ago
Communications Consultant Communications, Marketing and Public Affairs

Communications Consultant Communications, Marketing and Public Affairs

Mackenzie HealthRichmond Hill, Ontario, Canada
Full-time
As part of Mackenzie Healths Communications and Public Affairs Team the Communications Consultant is responsible for the development coordination and implementation of effective communications and ...Show moreLast updated: 5 days ago
QA / RA Associate

QA / RA Associate

fluidigmMarkham, ON, CA
Full-time
Job Locations CA-ON-Markham Req No.Category Quality Assurance / Regulatory Type Regular.It is an extraordinary time for Standard BioTools. Our technology is empowering customers to improve life thro...Show moreLast updated: 30+ days ago
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Lead Licensing Specialist

Lead Licensing Specialist

GE VernovaMarkham, Ontario, Canada
3 days ago
Job type
  • Full-time
  • Permanent
Job description

Job Description Summary

The Canada Lead Licensing Specialist Regulatory Affairs based in Canada will complete various technical licensing work scopes in Canada including new reactor licensing for the BWRX-300 Advanced Nuclear Project operating fleet licensing support customer plant support on GE Vernova Hitachi Nuclear Energy (GVH) / Global Nuclear Fuels (GNF) nuclear methods and working with GVH / GNF Engineering and Regulatory Affairs teams on major projects in the areas of mechanical systems or fuels.

Job Description

Essential Responsibilities

As the Lead Canada Licensing Specialist Regulatory Affairs you will perform the following for GVH reactors to be deployed in Canada :

  • Participate under the direction of the Canadian Technical Leader Regulatory Affairs in task associated with the nuclear regulatory review process with the Canadian Nuclear Safety Commission (CNSC) applicable to mechanical systems and / or fuel for the BWRX-300.
  • Support preparation and submittal of Preliminary Safety Analysis Report (PSAR) Pre-Operational Safety Analysis Report (POSAR) and Final Safety Analysis Report (FSAR) documentation and other license application documentation for BWRX-300 license application activities in accordance with CNSC regulatory requirements and guidelines and with input from the GVH BWRX-300 Project Team.
  • Support preparation and conduct of technical and licensing presentations to CNSC staff regarding BWRX-300 license applications and coordinate and prepare responses to the customer or regulator in the areas of safety analysis reactor core design and other applicable areas.

Required Qualifications

  • Bachelors Degree in a science or engineering discipline from an accredited university or college with a minimum of 5 years related professional work experience OR Masters Degree in a science or engineering discipline from an accredited university or college with a minimum of 3 years of related professional work experience.
  • Minimum of 5 years of experience performing or providing input into nuclear safety evaluations applicable to safety analysis at nuclear power plants including experience in CNSC regulatory documents and Canadian Standards Association (CSA) Standards.
  • Minimum of 5 years of experience involving complex projects and providing regulatory guidance and feedback to support those projects.
  • Eligibility Requirements

  • For Canada GE will only employ those who are legally authorized to work in Canada for this opening.
  • This position will report onsite to the Markham office 2 days a week (Tuesdays and Thursdays).
  • Desired Qualifications

  • Five (5) or more years of experience with Canada nuclear requirements and guidance and on-site nuclear reactor experience.
  • Nuclear engineering or mechanical engineering degree with experience in nuclear power plant operation.
  • Working knowledge of boiling water reactor (BWR) systems fuel or operations with specific experience with Advanced Boiling Water Reactor (ABWR) or Economically Simplified Boiling Water Reactor (ESBWR) engineering or licensing desired.
  • Experience and demonstrated effectiveness in working or communicating with nuclear regulators experience working with nuclear industry groups and international licensing experience.
  • Effective interpersonal and facilitation skills and ability to prepare highly technical documents.
  • Externally focused : takes action to enhance the reputation of the company / represents the company well at all opportunities.
  • Clear thinker : communicates messages clearly and concisely with the ability to make decisions with speed and accuracy based on the best available information / ability to sift through complex information and focus on critical few priorities.
  • Assess potential impacts of regulatory landscape on business and customers.
  • Strong business and financial acumen.
  • Ability to work effectively with technical leaders.
  • GE will only employ those who are legally authorized to work in Canada for this opening.

    This position requires access to and / or use of information subject to U.S. Export Control Laws which mandate all citizenships (including dual citizenships) be from the U.S. Department of Energys List of Generally Authorized Countries (10 CFR Part 810 Appendix A which includes Canada and can be found here : unless a specific authorization from the U.S. Department of Energy is obtained or unless you are a U.S. citizen U.S. national U.S. permanent resident or protected individual under the U.S. Immigration and Naturalization Act (8 U.S.C. 1324b(a)(3)). More information can be found here : https : / / must have legal authorization to work in Canada and any offer of employment is conditioned upon the successful completion of a background investigation. The drug screen requirement in the background check process is not required if the role is based in Canada .

    Strong consideration will be given to Indigenous persons. The term Indigenous refers to individuals who identify as being descended from the original inhabitants (the first peoples) of what is now known as this context Indigenous people are First Nations Métis and / or Inuit.

    #LI-BB1

    Additional Information

    Relocation Assistance Provided : No

    Required Experience :

    IC

    Key Skills

    Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

    Monthly Salary Salary : 300 - 300