Regulatory Affairs Project Manager
2 weeks ago
We are working with an innovative biopharmaceutical company who are in the early stages of drug development. To support their goals, they need a Regulatory Affairs Project Manager to join the team and ensure their new drug goes all the way from inception through to FDA approval and market.
It will be an exciting but challenging position which is a perfect fit for somebody who has a proven track record of taking life changing drugs from conception to market.
Objectives
Project Management
- Ensure the business gains GMP accreditation. This person should have extensive experience with bringing drugs from R&D to market and everything that it entails.
- Develop strategic plans, roadmaps, schedules etc. to clearly outline how the implementation/project is structured and all the tasks that need to be accomplished in order to achieve their goals.
- Serve as the main liaison between contractors/suppliers, and regulators.
- Vet contractors/ suppliers and review their work
Regulatory Compliance
- Liaise with the FDA/Health Canada and lead the team through the regulatory process with those agencies.
- Lead and oversee the preparation and submission of all regulatory documents, including the IND application, as well as data required for any regulatory submissions.
- Coordinate and manage regulatory inspections and audits.
Quality Management & Validation
- Responsible for the establishment of the Quality Management System (QMS), which covers all aspects of the operation.
- Lead and oversee the creation and implementation of the Validation Master Plan (VMP) and associated validation documentation for the premises, equipment, computer systems etc.
- Lead and oversee the creation of the risk management plans including things such as FMEAs etc.
- Lead and oversee the development of product specifications for raw materials, in process products, finished products, environmental monitoring, stability etc.
- Lead and oversee the creation of SOP’s throughout the organization.
- Oversee the technical development of manufacturing protocols (P&ID’s, PFDs, SOPs etc), including defining critical process parameters and validation strategies.
- Lead and oversee supplier/vendor qualification and associated process/procedure.
- Lead and oversee cleaning validation for all aspects of the operation.
Training and Knowledge Transfer
- Act as the SME for all things GMP and pharmaceutical manufacturing related.
- Ensure that MMB has the right internal personnel in place to execute on project delivery.
This role is required on-site 5 days a week.
-
Regulatory Affairs Manager
3 weeks ago
Canada, CA Sycamore Informatics, Inc. Full timeDesignation Manager, QRCExperience 5+ yearsJob Responsibility Responsible for ensuring SI products and services are compliant to relevant government and industry regulations including but not limited to: 21CRF11, ISO 27001, ISO 9001, ICH GCP, GAMP5, and Guidance for Industry - Computerized Systems used in Clinical Trials. Assist in leading QRC for Quality...
-
Environmental and Regulatory Planner
3 weeks ago
Canada, CA Brunel Full timeJob Description: Environmental and Regulatory PlannerLocation: Canada Company Overview: Brunel has partnered with a leading Oil and Gas company, and embarking on a large project located in Northern Canada. We are committed to providing innovative solutions that balance economic development with environmental protection.Position Overview: We are seeking an...
-
Manager, External Affairs
3 weeks ago
Canada, CA Fintechs Canada Full timeIn a rapidly evolving financial services landscape, Fintechs Canada is a not-for-profit association that serves as the unified voice of Canada’s fintech sector. With a mission to make the financial sector more responsive to the needs of Canadains by removing barriers to competition and innovation, Fintechs Canada is more than just another industry...
-
Senior Project Manager
2 weeks ago
Canada, CA Vaco Full timeLocation: 100% remote in QuebecOur client is seeking a Senior Project Manager with preferred experience in insurance or financial institutions, to lead projects in the auto insurance sector. The role focuses on online sales, digital transformation, migration, and risk management. The ideal candidate will have expertise in Agile and SAFE methodologies, with...
-
Project Manager
2 weeks ago
Canada, CA Hays Full timeJob Title: Project Manager (Multifamily Construction)Location: Calgary, ABHays are currently working with an established multifamily builder in Calgary who specialises in both condo and town-home builds.They are currently looking for a Project Manager to join there team.As a Project Manager, you will oversee multifamily construction projects from contract...
-
Project Manager
2 weeks ago
Canada, CA Delnor Construction Full timeWelcome to Delnor Construction!This is where innovation meets craftsmanship to redefine the landscape of construction excellence. With a rich legacy spanning over forty years, Delnor has consistently set the standard for quality, efficiency, and client satisfaction in the construction industry. Our unwavering commitment to delivering exceptional projects,...
-
Project Manager
5 days ago
Canada, CA Airswift Full timeAirswift is seeking a Project Manager to join one of our major Mining clients on a 1-year contract with the possibility of being renewed. This role sets on remote scheduling with frequent travel required to effectively manage the project (details below).We are looking for a Project Manager to successfully deliver a number of small to medium-sized projects...
-
Construction Project Manager
2 weeks ago
Canada, CA Covertite Eastern Ltd Full timeWE ARE HIRING A FULL-TIME PROJECT MANAGER IN LIVERPOL NOVA SCOTIACovertite Group of Companies is currently seeking a Project Manager in Liverpol Nova ScotiaThe individual works closely with the operations team, multidisciplinary teams, and field staff to coordinate all aspects of the project.Responsibilities:Manage the overall project performance and status...
-
Engineering Manager
2 weeks ago
Canada, CA Cain & Associates Full timeCivil/Structural ManagerLocation: Canada (preference for British Columbia or Alberta)Position Overview:We are seeking a highly skilled and experienced Civil/Structural Manager to join our dynamic team. The ideal candidate will have a Professional Engineer (P. Eng) designation in either British Columbia, Alberta, or the USA, along with a proven track record...
-
Mainframe Project Manager
3 weeks ago
Canada, CA TV2 Consulting Full timeThe candidates for this position will need to have senior level subject matter expertise in the following areas: Data at rest and motion encryption, IMS, Db2, VSAM, ICSF, Key management, SAS, MXG, PCOMM, VTAM, TPX,MULTSESS, TCPIP, SMF, SMS, Certificates, ACF2 and RACF, ZOS operating system, capacity forecasting and performance management.RequirementsMentors,...
-
Technical Project Manager
5 days ago
Canada, CA Sanctuary AI Full timeJob descriptionYour New Role and TeamSanctuary AI is looking to hire a Technical Project Manager - Customer Projects. As a versatile team member, you'll play a crucial role in the planning, execution, and completion of strategic customer projects.Reporting to the Chief Operating Officer, our new Technical Project Manager’s responsibilities will span...
-
Technical Project Manager
2 weeks ago
Canada, CA Intuitive.Cloud Full timeAbout us:Intuitive.Cloud is one of the fastest-growing (INC 5000, CRN) Cloud & SDx solution and services companies supporting enterprise customers on a global scale. Intuitive is an "Engineering Company" delivering measurable value and key business outcomes.Intuitive Superpowers:- DataOps & AI/ML- Cloud Native, AppSecOps, DevSecOps- Cloud Migration &...
-
Implementation Project Manager
3 weeks ago
Canada, CA IG Recruit Full timeJob Title: Implementation Project ManagerLocation: North America or USA - fully remote Company: Software Development Our client, a leader in revolutionizing customer experiences through a cutting-edge CCaaS platform, trusted by globally recognized brands, is seeking a dynamic Project Manager with contact centre expertise for an exciting opportunity....
-
Digital Project Manager
5 days ago
Canada, CA Pattern Brands Full timeAt Pattern Brands, we live to curate products that turn your everyday routines into joyful rituals. We are a fast growing portfolio of brands in the home category looking for a digital project manager to focus on the digital platform of our largest eCommerce brand and manage the relationships with our third-party development team. The ideal candidate will...
-
Project Manager
3 weeks ago
Canada, CA BrickRed Systems Full timeWe are seeking a skilled and experienced Project Manager with a strong background in Title insurance, project management, Agile methodologies, and technical expertise in Azure DevOps / TFS, .Net, and related technologies. The ideal candidate will have a minimum of 3 years of project management experience, with a proven track record of successfully delivering...
-
Information Technology Project Manager
1 week ago
Canada, CA FinSocial Full timeFinSocial is seeking a motivated and enthusiastic IT Project Management Intern to join our dynamic team for a 6-month unpaid internship/co-op. This opportunity offers a unique chance to gain hands-on experience in designing, implementing, managing, and evaluating IT projects across our organization. The ideal candidate will be comfortable handling multiple...
-
Project Manager – Meetings Logistics
5 days ago
Canada, CA X4 Communications Full timeProject Manager – Meetings Logistics A boutique medical communications agency, based in Toronto, is looking for a Project Manager to join the team and lead on all meetings logistics. The role is remotely set up, with travel only required to a portion of live meetings!The Medical Communications Agency:This is a boutique, privately held, medical...
-
Marketing Project Manager(Remote)
3 weeks ago
Canada, CA MedReview Inc.. Full timeWho is MedReviewJoin our team at MedReview, a pioneering authority in payment integrity for over 40 years. As a physician-led organization, we are dedicated to ensuring healthcare claims accurately represent the care provided. Through timely and precise independent audits and clinical validation of provider claims, we have saved our clients billions of...
-
Senior Bilingual Project Manager
2 weeks ago
Canada, CA LeverageTek IT Solutions Full timeLeverageTek is actively seeking a Senior Bilingual Project Manager for a 3-month contract with its Montreal-based customer.Work LocationThe successful candidate will be required to work on-site at the customer’s office in Montreal, QC, on a hybrid basis.Language RequirementsBilingual in French and English essential.Key TasksWork closely with internal and...
-
Project Manager
2 weeks ago
London, Canada Metropolitan Area, CA Hays Full timeHays has partnered with a large leading contractor who have offices across Canada. Our client primarily carries out major institutional, industrial and commercial projects across Canada and they are fueled by a deep vision powered by innovation and a very skilled and committed team. The open role is for an experienced Project Manager to join the team...