Regulatory Affairs Specialist
Job Description SummaryThe Regulatory Affairs Specialist role at STEMCELL is to support the Regulatory Affairs Department in all global regulatory submission and regulatory document management activities that 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
Assist in preparation, review and maintenance of regulatory documentation and submissions to regulatory bodies including but not limited to Technical Files, Master Files for STEMCELL’s products.
Identify, interpret and apply global regulations applicable to STEMCELL’s products and processes.
Assist in maintenance of Regulatory Document Management systems.
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
Conduct documentation review and approval to meet submission and regulatory requirements for raw materials and finished products.
Identify and evaluate and fill gaps related to compliance that cause risk to the business and regulatory certifications.
Bachelor’s Degree in a relevant field.
1-2 years’ experience in Regulatory Affairs and/or Quality Assurance in the Biotech/ Pharmaceutical/ Medical Device industry or equivalent.
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.
Computer literacy especially with regards to database management and document formatting.
Project management and time management skills.
Ability to question and not always be satisfied with the status quo.
Willingness to learn and assume new responsibilities.
Good interpersonal skills.
Effective communicator and listener.
Self-motivated and independent work ethic.
Ability to handle multiple tasks in a fast paced and changing environment.
Flexible, with a good tolerance for ambiguity.
A problem solver.
Specialized knowledge (preferred but not mandatory): Knowledge of country specific regulatory requirements (e.g., cGMPs including 21 CFR 820s, ISO 13485 / 9001, FDA, Health Canada, European IVD device regulations, etc.). Experience with preparation of regulatory submissions such as DMF, IND, CMC is desirable.
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.
To apply please select the apply button. You will then be directed to a login screen asking you to set up an account. You must set up an account in order to apply.
Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number.Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!