Regulatory Affairs Specialist
Job Description SummaryAre you a quality-driven professional, with excellent attention to detail, and looking to advance your career in regulatory affairs? If you’re looking to work in a collaborative environment, apply your expertise in global regulations, and help drive forward projects in the biotechnology industry, this may be the role for you!
As a Regulatory Affairs Specialist at STEMCELL Technologies, you will have a significant role in evaluating compliance risk regarding domestic and global regulatory standards and contribute to the success of our innovative products. Based on your knowledge of regulatory guidelines, you will support the submission of regulatory documentation and exercise your judgment to work in complex practices and processes by identifying downstream impacts and managing risks. This is a fantastic opportunity to support cutting edge research in the life sciences field, while exploring the complexity of the global regulatory landscape!
Duties and Responsibilities
Support the preparation, review, and maintenance of regulatory documentation and submissions
Identify, interpret, and apply regulatory guidance to STEMCELL’s processes and products
Maintain and further develop working knowledge of domestic and international regulations
Conduct documentation review and approvals to meet submission requirements for raw materials and finished products
Identify, evaluate and fill gaps related to compliance risk
Knowledge and Qualifications
Bachelor’s degree or Diploma in science or a related field, with a minimum of two years of Regulatory or Quality experience in a regulated industry
Experience with electronic Common Technical Document (eCTD) format submissions, especially Module 3 and Chemistry Manufacturing, and Controls (CMC)
Experience writing or reviewing sections of regulatory submissions such as De Novos, 510(k), PMAs, Master Files, IVDR Technical Documentation would be an asset
Working knowledge of ISO, GMP, FDA, and EU Standards and Directives strongly desired
Familiarity with the variety of regulatory submissions in a North American market is desirable
#Nonbench #LI-Hybrid #LI-AS1
STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. Scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 2300 employees globally, most with scientific or engineering degrees, STEMCELL is proud to be the largest biotechnology employer in Canada.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.
STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.
As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.
The annual base salary for this job ranges from:$68,595.00 - $92,800.00
STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.
NOTE: STEMCELL’s vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process.
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