The Senior Regulatory Affairs Specialist role at STEMCELL assists in the development and implementation of strategies to meet compliance to applicable regulations. It gives the opportunity to exercise independent judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues. STEMCELL is a dynamic workplace that pursues cutting edge technologies and practices which translates to this role managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.
Duties and Responsibilities:
Identify, interpret and apply global regulations applicable to STEMCELL’s products and processes
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies
Lead project teams as the compliance representative to assess requirements, and develop and execute plans to support corporate initiatives
Lead in preparation and review of regulatory documentation and submissions to regulatory bodies including but not limited to Technical Files, Drug Master Files, Site registrations, 510(k)s and risk analysis impact determinations to products
Conduct documentation review and approval to meet importation/exportation requirements for raw materials and finished products
In collaboration with Supply Chain, ensure timely resolution to compliance issues relating to the global transport of STEMCELL products
Support Key Relationship Management Accounts with increased regulatory requirements
Create and lead training initiatives specific to quality and regulatory
Conduct internal and external audits to measure compliance to relevant standards, directives, regulations and policies.
Prepare, review and implement procedures and processes across the organization
Identify and evaluate and fill gaps related to compliance that cause risk to the business and regulatory certifications
Provide leadership and guidance to all staff as related to quality and regulatory practices
Education: Master’s or Bachelor’s Degree or Technical Diploma in relevant field.
Experience: 7-10 years’ experience in Regulatory Affairs and/or Quality Assurance in the biotech industry or equivalent.
Specialized knowledge: Knowledge of country specific regulatory requirements (e.g., cGMP 820s, ISO 13485 / 9001, FDA, Health Canada, European IVD device directives, etc.) is an asset. Experience with preparation of regulatory submissions such as DMF, IND, CMC is an asset.
Skills: Proven ability to coordinate and execute responsibilities relating to Regulatory Affairs. Excellent technical and scientific report writing and strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes. Excellent communication skills.
Abilities: Demonstrated ability in project management and time management to ensure completion of tasks on a priority basis. Exercises judgment within undefined practices and procedures that may be incomplete or complex.
Other characteristics such as personal characteristics: Comfortable making presentations before groups; ability to question and not always be satisfied with the status quo; willingness to learn and assume new responsibilities; good interpersonal skills; self motivated and independent work ethic; ability to handle multiple tasks in a fast paced environment.
STEMCELL Technologies Inc. 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 significant career development opportunities.
Internal Number: R0001721
About STEMCELL Technologies
STEMCELL is growing fast, and we're always looking for smart, motivated people to join our team. STEMCELL is the largest biotechnology employer in Canada, and is proud to have been named Company of the Year by BIOTECanada and Life Sciences Company of the Year by Life Sciences BC in 2015, as well as having received three BC Export Awards in 2016, including Exporter of the year!
STEMCELL is guided by our love of science and our passion for quality. Our company values of innovation, quality, integrity, collaboration and responsiveness drive our unrelenting pursuit of scientific knowledge. We stand by our customers to provide outstanding products, technical support and training.
STEMCELL brings together a highly skilled and dynamic group. As a company of Scientists Helping Scientists, the majority of our 900-person team has a science degree, with more than one-third of employees holding an MSc or a PhD. We also employ engineers, MBAs, CPAs, and other professionals in a variety of departments.
For candidates interested in lab-based opportunities, our large Research and Development group is always looking for skilled research scientists and associates to plan and develop new pro...ducts. Our Manufacturing, Process Development and Quality Control teams are also growing, and need scientists and engineers to support the manufacture and testing of our high-quality products. Candidates with training in fields such as cell biology, molecular biology, immunology or chemistry are encouraged to visit our Career Listings to learn more about the positions available with these groups.
STEMCELL also offers a large range of career opportunities for people with scientific training and expertise, but who are looking for a career away from the bench. Roles in Sales, Product Management, Science Communications & Marketing, Technical Support, Business Development & Licensing, Business Operations, Quality Assurance and Regulatory Affairs require a combination of science expertise and business acumen and provide exciting career opportunities for scientists outside of the lab.
Corporate teams such as Finance & Accounting, Facilities, Human Resources, Information Technology and Systems and Supply Chain Operations are also essential to our success. We offer many opportunities for career advancement outside of science, and actively seek candidates interested in working for an international, fast-paced, growing company.