Title: Quality and Regulatory Associate
Location: Burnaby, British Columbia, Canada
- Advance your career with a growing pharmaceutical company!
- Use your science background to make a positive impact in the lives of others!
- Competitive remuneration and benefits package!
Medipure’s mission is to revolutionize drug discovery and bring innovative and safe medication for the treatment of pain, anxiety and skin disorders. We bring novel prescription medicines to market, providing patients with serious conditions valuable solutions that improve quality of life through the development of safe and effective endocannabinoid-based therapeutics.
Through rapid cost-effective product development, by addressing market needs, and establishing strategic partnerships, we seek to maximize the value of our products and provide innovative treatments for targeted diseases. For information, please visit our website.
About the Opportunity
Medipure is rapidly growing and we have an exciting opportunity for a Quality and Regulatory Affairs Associate to join our team at our R&D facility in Burnaby (B.C., Canada) on a full-time basis.
This position is ideal for someone who has experience in quality management and regulatory affairs in the pharmaceutical industry and wishes to learn and engage in exciting drug discovery projects and development company.
The duties will cover the areas of regulatory affairs and quality assurance.
1. Regulatory Affairs:
Ensures that The Company’s research programs and products are compliant with the regulations, acts and associated policies of the Canadian federal and/or provincial government. Notably: CDSA (Controlled Drugs and Substances Act), NCR (Narcotic Control Regulations)
- Maintains current regulatory knowledge for all relevant domestic and/or international standards, applying appropriate implementation strategies where required
- Prepares and reviews regulatory documentation and submissions to regulatory bodies including, but not limited to: Technical Files, site licenses/registrations, Drug Master Files (DMFs) and risk analysis impact determinations
- Reviews documentation for approval in the local/global transport and distribution of R&D materials, resolving compliance issues when necessary
- Prepares regulatory submissions, inventory reports, and coordination of responses to Health Canada
Provides real-time compliance support to the R&D team
2. Quality assurance:
Sets up and maintains a documentation system, ensuring all internal filing requirements are maintained properly
Drafts, revises and implements company procedures, policies and quality documents to ensure compliance across all departments
- Trains all personnel with QC and QA principles
Performs all QA functions including, but not limited to: Batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention
Prepares analytical reports and Certificate of Analysis (CoA) for R&D products
Ensures that the company adheres to GMP, GLP, ISO 9001 and applicable acts/regulations
Prepares and implements the procedures, policies to get facility accreditation (GLP, GMP, and ISO9001)
Reviews production and laboratory records, assisting in internal audits and self-inspections
Conducts external audits for suppliers and service providers
Performs equipment and instrument calibration/validation and preventive maintenance duties as required
- Master’s or Bachelor’s Degree or diploma in relevant degree areas, including Biochemistry, biotechnology, chemical, and physical sciences, life sciences, pharmacology or pharmacy.
- Minimum 4 – 5 years experience in regulatory affairs, compliance, quality assurance, and document management in the biotech industry or equivalent.
Experience in an environment adhering to federal governmental regulation (i.e: Health Canada, FDA, etc.) is an asset.
- Strong GMP pharma/QPIC experience is preferred.
- Experience in document control and management is an asset
- Knowledge of country-specific regulatory requirements is an asset. Experience with preparing regulatory submissions is an asset.
- Understanding of both legal and scientific matters. Proven ability to grasp new concepts quickly. Excellent technical and scientific report writing. Strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures, and processes. Excellent communication skills. Analytical, methodical and diligent with outstanding planning abilities.
- Prior experience interacting with auditors and regulators.
- Familiarity with CDSA and NCR and risk management controls.
Strong computer, scientific, and organizational skills
You will do well in this role if you have the ability to work independently and with limited supervision. Strong problem solving, troubleshooting, multitasking, and decision-making skills are essential, as is good time management and prioritization skills. You must be comfortable working in a fast-paced environment.
Above all, you will have excellent written and verbal communications skills and the ability to give presentations as required. Strong team building, training, and coaching skills will be the key to your success in this role.
If you want to further develop your skills and build a long-term career with a growing company – Apply Today!
About the Benefits
Upon joining Medipure you will be welcomed into a dynamic and multicultural team. In exchange for your hard work and dedication, you will receive a competitive annual salary plus a comprehensive benefits package.
And that's not all! When you join Medipure, you will have the ability to define your own career path while working with an engaged and excited team.