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 the right internal personnel in place to execute on project delivery.
This role is required on-site 5 days a week.
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
1 week ago
Kelowna, Canada Biotech Rec Full timeWe 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 b
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
6 days ago
Kelowna, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, BC, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, BC, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
13 hours ago
Kelowna, BC, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, BC, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
2 weeks ago
Kelowna, British Columbia, Central Okanagan, Canada Biotech Rec Full timeWe 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...
-
Regulatory Affairs Project Manager
1 week ago
Kelowna, BC, Canada EightSix Network Inc Full timeWe 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...
-
Political Affairs Internship
4 weeks ago
Kelowna, Canada Borgen Project Full timeAre you passionate about making a difference in the world?Look no further!The Borgen Project is an international organization that works at the political level to improve living conditions for people impacted by war, famine and poverty.With 20 years of experience in the advocacy space, The Borgen Project has worked to support the passage of numerous bills...
-
Assistant Project Manager
7 days ago
Kelowna, Canada School District #23 (Central Okanagan) Full time**ASSISTANT PROJECT MANAGER - OPERATIONS*** It is acknowledged that Central Okanagan Public Schools operates within the unceded, Traditional Territory of the Okanagan syilx peoples. The School District enrolls approximately 24,500 students (including over 3,000 students who self-identify as having Indigenous ancestry). Central Okanagan Public Schools is...
-
IMIT Project Manager
1 month ago
Kelowna, Canada Interior Health Authority Full timeInterior Health is looking for an experienced IMIT Project Manager to join our team on a full time permanent basis out of our Kelowna location. What we offer: - Employee & Family Assistance Program - Employer paid training/education opportunities - Employer paid vacation - Medical Services Plan - Employer paid insurance premiums - Extended health & dental...
-
Jr. Project Manager
2 weeks ago
Kelowna, British Columbia, Canada Jim Dent Construction Full timeSalary: Jim Dent Construction based in Hope, BC is a long-standing leader in Heavy Civil Construction projects throughout BC. With an established history of completing complex projects, Jim Dent Construction has built a reputation of getting the job done. With a diverse team providing technical experience and advanced skills to deliver results the DENT team...
-
Senior Project Manager | IMIT
1 month ago
Kelowna, Canada Interior Health Authority Full timeInterior Health is looking for an experienced Senior Project Manager, IMIT to join our team on a full time permanent basis out of our Kelowna location. What we offer: -Employee & Family Assistance Program -Employer paid training/education opportunities -Employer paid vacation -Medical Services Plan -Employer paid insurance premiums -Extended health &...
-
Project Coordinator
2 weeks ago
Kelowna, British Columbia, Canada Ram Environmental Response Ltd. Full timeSalary: Hourly $27-$30RAM Environmental Group Our Mission We want to disrupt the environmental sector with a proud passion for community, first-nation partnerships, and use of inventive and adaptive tools and techniques to deliver honest, empathetic, and tailor-made environmental response and remediation services. Our Advantage The RAM Advantage is our...
