Regulatory Affairs
Part-time
PIONEER THINKING CONSULTING CORPORATION
We are seeking an experienced professional in Regulatory Affairs to join our team.
This role will be responsible for managing and maintaining regulatory compliance for our upcoming products, ensuring that we meet all requirements set forth by PMRA (Health Canada). Main Duties:Overseeing the preparation and submission of regulatory documentation to PMRA Health Canada with following tasks:
Communication re: deficiencies and requirements
Preparation of Deficiencies notice
Preparation of DER and SPSF
Preparation of e-index
Review of impurities of concern
review of manufacturing process
review of analytical method validation
review of batch data
review of physical chemical studies and data
review of storage stability
updating deficiencies notice and documents
new Use form
Label preparation
Prepare, collect data on pesticides for purpose of registration (technical, MP, EP)
Developing and implementing strategies to mitigate regulatory risks.
Analyze data gap and waiver strategies. Assist with negotation on data compensation Qualifications:
University Degree, B.Sc. or higher in Crop Protection or related field.
Minimum 5 years of experience in PMRA Regulatory Affairs.
Minimum 5 years of experience in Category A,B,C,D,L.
Proven track record of regulatory compliance and management.
Mastered Pest Control Products Act and Pest Control Products Regulations Hybrid work place will work for the right candidate. on the application, you must state clearly how long you have worked with PMRA and what are the products you have worked on for PMRA registration.
Vacancy posted 25 days ago
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