Position Title: Manager, Regulatory Lifecycle Management
Reports To: Director, Regulatory Affairs
Location: Hyderabad, Telangana, India

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 Regulatory Affairs Manager 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 RESPONSIBILITIES
Preparation, 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 valuable 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 maintain

📌 Manager, Regulatory Lifecycle Management (Hyderabad)
🏢 SteriMax
📍 Hyderabad