Senior Associate, Regulatory Affairs

POSTITION: Senior Associate, Regulatory Affairs ABOUT OUR GLOBAL TEAM SteriMax is a proudly Canadian company serving the Canadian healthcare system, with strategic direction and decision-making anchored in Canada. To support our growing global operations, we have expanded select roles to our India office, positioning our team closer to key manufacturing and operational partners across Asia. This enables more effective collaboration and stronger execution - while maintaining the high standards and quality SteriMax is known for.

POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY RESPONSIBILITIESPreparation, reviewing and submission for assigned projects.Provides cross-functional review and strategy from a regulatory, scientific and technical viewpoint.Coordinates the assembly, including requesting and/or generating, of documents to support submissions including generic injectables, and may also include complex generics and biosimilars per established business processes and systems.Evaluation and good interpretation skill of post approval changes.Hands-on experience in lifecycle management, which includes:Assessing the regulatory impact of proposed product changes, such as labeling updates and manufacturing process modifications.Providing regulatory strategies and timelines for Chemistry, Manufacturing, and Controls (CMC) lifecycle management documents.Submitting post-approval changes to Health Canada, including supplements (Level I) and annual notifications (Level III).Collaborating with cross-functional teams to ensure the smooth implementation of changes while maintaining regulatory compliance.Updating the database with submission details and status.Builds and maintains a healthy working relationship with business partners.Executes labelling activities, preparing the product monograph and coordinating the generation of mock-up artwork with senior artwork specialistEvaluates and ensures that submissions are accurate and meet format and content requirements as per Health Canada regulations, completing dossier publishing using eCTD softwareCommunicates effectively with internal departments (Product Development, Quality, Supply Chain, Marketing, etc.) to assist in the continuation of product supplyContributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvementMaintains 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 dataDemonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical mannerStrong understanding of Health Canada and ICH regulatory guidance documents and policiesProficient computer skills, including MS Office applications and Adobe Acrobat; Experience with eCTD publishing tools is an assetDemonstrated understanding of sterile product manufacturing is preferred QUALIFICATIONSUniversity Degree in Science or Life Sciences. Post-graduate certification in Regulatory Affairs program preferred.Must have 10-15 years of experience with drug submissions for Health Canada. Sterile injectable experience preferred.Ability to work with changing priorities that involve multiple and concurrent projects.Excellent oral and written communication skills.Strong understanding of Canadian regulatory guidance documents and policies, as well as ICH and international guidelines.