Clinical Regulatory Specialist | (C-904)

Clinical Regulatory Specialist | (C-904)

12 Jul
|
ZYUS
|
Corman Park No. 344

12 Jul

ZYUS

Corman Park No. 344

Your Contribution: Coordinate, write, review, obtain, maintain, and archive the required documents for regulatory submissions in the EDMS. Responsible for reviewing all documentation from a regulatory perspective to ensure clarity, consistency, completeness. Responsible for the documentation of regulatory submissions for new products, changes to approved products, and clinical trial applications. Assist in short-term and long-term planning of regulatory submission initiatives. Assist in the management of IRB submissions and IRB and site correspondence. Support the Clinical Operations Team on GCP and ICH guidelines for new sites, projects, and collections. Assess and advise on Target Product Profile (TPP).

Work with the functional internal and external regulatory groups on cross-product sections or stand-alone documents to ensure content is aligned with the Target Product Profile (TPP). Coordinate study-startups with the Clinical Operations Team by tracking IRB submissions, regulatory file maintenance and creation, and regulatory compliance for new and existing clinical sites. Identify and mitigate regulatory risks throughout the project Risk Register. Responsible for keeping abreast of current legislation, regulatory guidelines, and regulatory changes, and interpreting its implications on the drug development process, authorization process, and clinical regulatory strategy. Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities. Proactively provide input when legislative changes are being discussed and proposed. As a member of the project team, contribute to the designing of the development program.

Support the determination of key milestones for product and portfolio-specific regulatory documents to be submitted to authorities. Ensure compliance of clinical trials with federal and applicable regulatory agency requirements, Good Clinical Practices, and Standard Operating Procedures. Interact with internal project teams for all parts related to clinical regulatory aspects of a given project/product-related discussion and provide strategic and Regulatory Affairs input. Assist project teams in preparation, handling, and archiving of revised clinical study documents at the study conduct stage. Oversee the Clinical Regulatory Team, including conducting performance reviews, providing feedback, and fostering a positive work environment. Collaborate with Regulatory and Quality Affairs on clinical data review. What it Takes: MSc in Health Sciences or related field with 3-5 years experience in a clinical research, pharmaceutical,

regulatory, or legal setting. Prior management experience will be considered an asset. Working knowledge of the Board of Health regulatory requirements (EMA, FDA, Health Canada, etc.). Has a good understanding of the health product sector and drug development. Knowledge of legislation governing medical products and has a good understanding of the technicality involved in regulatory submissions throughout the life cycle of a product is considered an asset. Ability to work in accordance with GCP & ICH guidelines, maintaining confidentiality at all times. Skilled in project management with the ability to prioritize and effectively manage the position workload. Excellent organizational and analytical skills with a high attention to detail. Excellent written and oral communication skills are required. Ability to use Microsoft Office (Word, Excel,

and Outlook). Benefits of Joining Our Team At ZYUS, we care about our people. Our total rewards package includes comprehensive benefits, retirements savings, paid time off, on-going training and development. We thank all the applicants; only those selected for an interview will be contacted. To apply, please email a copy of your resume to

The original job offer can be found in Kit Job:
https://www.kitjob.ca/job/32231398/clinical-regulatory-specialist-c-904-corman-park-344/?utm_source=html

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