Coordinates, prepares, or reviews regulatory documents that contribute to domestic and/or international submissions to ensure scientific rigor, accuracy, clarity of presentation, and compliance with applicable regulations.
Reviews documents to ensure accuracy of text, layout, and references; compliance with Zymeworks standards; and overall consistency, and clarity.
Supports the publishing and submission of documents to regulatory authorities.
Maintains and contributes to regulatory document preparation best practices and processes, suggesting improvements and innovations as needed.
Assists with maintaining and managing health authority interactions within the regulatory information management system (oruse RIM). May initiate, contribute to, or update standard operating procedures, work instructions, or policies.
Identifies and understands new and existing guidance documents, regulation, international standards, or consensus standard and provides interpretive assistance.
Identifies, understands and interprets new and existing applicable guidance documents, regulations, international standards, or consensus standard and applies to business practices.
Provides regulatory input, advice and guidance within the department and organization
Supports corporate change management initiatives within the department.
Recommends solutions to mitigate risk of proposed regulatory strategies.
Bachelor's degree in a related field
A minimum of 2 years of related work experience with drug or therapeutics biologic products for an associate position and 5+ years for a specialist position.
Familiarity with drug development, guidelines and regulations (eCTD, FDA/ICH and cGXP).
Ability to work effectively with limited direction.
Strong written and oral communication skills.
Demonstrated ability to work well cross-functionally with various people and groups.
Highly organized and detail oriented with effective time management and ability to prioritize projects in a fast-paced environment.
Ability to accurately review materials including graphics, texts, and web sites.
Strong proficiency with Microsoft Office including Word, Excel, and PowerPoint as well as Adobe Acrobat
Familiarity with a DMS preferred
Internal Number: 1674
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.