Reporting to the Regulatory Affairs Director, the Senior Associate Regulatory Affairs will prepare regulatory submissions for complex injectable generic products and biosimilars; and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Senior Associate Regulatory Affairs will provide sound regulatory input during product development.
KEY RESPONSIBILITIES: - Coordinates the assembly, including requesting and/or generating, of documents to support submissions including complex generics and biosimilars (NDS, ANDS, SNDS, SANDS, DINA, etc.) per established business processes and systems
- Liaises with external partners/CMOs to request documents and ensures regulatory compliance is met for the purpose of filing successful submissions
- Builds and maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters.
- Evaluates and ensures that submissions are accurate and meet format and content requirements as per Health Canada regulations
- Communicates effectively with internal departments (Quality, Supply Chain, Marketing, etc.) to assist in the continuation of product supply
- Reviews, evaluates, prepares, and files deficiency responses for changes filed with Health Canada in a timely manner within given deadlines
- Contributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvement
- Maintains current awareness of Health Canada regulatory guidelines and shares knowledge with the department
TECHNICAL SKILLS: - Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner
• Knowledge of GMP requirements and QA/QC procedures
• Strong understanding of Health Canada and ICH regulatory guidance documents and policies
• Proficient computer skills, including MS Office applications and Adobe Acrobat; Experience with eCTD publishing tools is an asset - Demonstrated understanding of sterile product manufacturing is preferred
QUALIFICATIONS: - University Degree in Science or Life Sciences and post-graduate certification in Regulatory Affairs program
- Must have a minimum of 5 years of experience in drug submissions for Canada, preferably with parenteral dosage forms and biosimilars
