Regulatory Affairs Project Manager
4 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.
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