Senior Regulatory Affairs Specialist, Ancillary Materials
Job Description SummaryAre you ready to take the next step in your regulatory affairs career? Do you have a passion for strategic planning, worldwide information gathering, and building lasting relationships in the life sciences industry?
As a Senior Regulatory Affairs Specialist at STEMCELL Technologies, you will play a crucial role in ensuring compliance with global regulatory standards and driving the success of our innovative products. You will be the point of contact internally, providing critical information as part of strategic planning for long term timelines. Your expertise will be instrumental in fielding questions from our business development team, both from external customers and potential partners.
Duties and Responsibilities
Utilizing your strong FDA, Health Canada, and international regulatory background to navigate various regulatory landscapes
Managing De Novo, Master File, and other submissions and amendments with critical attention to detail
Fielding questions from business development for external groups, including customers and potential business partners
Interpreting global market regulations and communicating that understanding to internal cross-functional groups
Gathering reference information and preparing for external regulatory meetings and discussions
Knowledge and Qualifications
A minimum of three years of Regulatory or Quality experience in a regulated industry such as biotechnology, pharmaceutical, or other life science-related fields
Exposure to a breadth and variety of regulatory submissions in a North American market
Successful De Novo and Master File submissions are critical
The adaptability and ability to introduce new structures and processes to changing priorities
A proven ability to influence and motivate others from a hybrid work setting
#Nonbench #LI-Hybrid #LI-ML1
STEMCELL Technologies is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. 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, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. 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.
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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