Regulatory Affairs Specialist – Pharma
Our team in Etobicoke currently has an opening for a Regulatory Affairs Specialist Pharma
YOUR ROLE & RESPONSIBILITIES
- Supporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety.
- Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA’s & TA’s) in and English.
- Contribute as part of team to maintenance of EMEA document management system to keep product and supplier information up to date.
- Request product and supplier information directly from manufacturers and indirectly via other internal channels.
- Process Change Control Notifications.
- Maintain customer specific information such as completed questionnaires, supply chain agreements, QAA’s, TA’s in the designated database.
- Creation and ongoing update of product regulatory information in standardized information packs.
- Support of customer, regulatory and 3rd party audits.
- Reporting and documenting customer requests via KPIs.
YOUR PROFILE
Education and Experience :
- 2 years previous experience working with regulatory documentation.
- Knowledge of ISO9001, food safety or GxP systems.
- University degree in life sciences
- Knowledge of pharmaceutical industry requirements and regulations on APIs, Excipients and starting materials.
- Previous experience with the FDA (or another national competent authority) and their requirements.
- Team player, strong communication and interpersonal skills, with ability to work across all levels, and functions
OUR OFFER
- We aim to create an environment where the best people want to work, where they can turn their passion into their job and realize their full potential.
- Individual development, on-the-job training, and development programs designed to help our employees grow in their careers.
- Competitive pay and incentives.
- Various healthcare plan options as well as 401(k).
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