Regulatory Affairs Associate Full Time NEW

POSTITION: 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 DESCRIPTION:

The Associate, Regulatory Affairs will prepare regulatory submissions for complex injectable products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Regulatory Affairs Associate 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, DINA, etc.) per established business processes and systems
• Fulfills lifecycle management activities as needed to support the base business objectives and improve existing portfolio by compiling and submitting post-approval changes (SANDS, SNDS, Post DINA)
• 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:

• Bachelor’s Degree in Science or Life Sciences and post-graduate certification in Regulatory Affairs program
• Must have a minimum of 3 years of experience in drug submissions for Canada, preferably with parenteral dosage forms