Job Description Summary
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.Job Description 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.
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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!