Job Title: Assistant Manager – Regulatory Affairs (Canada Market)
Experience Required: Minimum 3 Years
Location: Gurgaon, Haryana (India)
Department: Regulatory Affairs
Number of Openings: 1
About the Role:
We are seeking an experienced Assistant Manager – Regulatory Affairs to support regulatory submissions and lifecycle management activities for the Canada market. The ideal candidate should have strong knowledge of Health Canada regulatory requirements, dossier review, regulatory strategy, labeling compliance, electronic submission formats, regulatory publishing, and regulatory document management.
The role will involve working closely with cross-functional teams to ensure regulatory submissions are accurate, technically compliant, and completed within defined timelines.
Key Responsibilities:
Regulatory Strategy & Module 1 Review
Review Module 1 documents for completeness, accuracy, and compliance with Health Canada requirements.
Develop and review regulatory filing strategies for new registrations, variations, responses, and lifecycle management activities.
Ensure dossiers meet country-specific regulatory requirements prior to submission.
Coordinate with cross-functional teams to obtain required documentation and information.
Labeling & Artwork Compliance Review
Review product labeling, packaging components, and artwork for regulatory compliance.
Ensure consistency between approved product information, dossier content, and packaging materials.
Provide timely regulatory feedback to internal stakeholders and clients.
Identify and mitigate labeling risks before submission or commercialization.
Regulatory Documentation & Archival Management
Maintain regulatory correspondence, submission records, approvals, and project documentation.
Ensure accurate and timely archival of regulatory documents in electronic repositories.
Update project trackers, submission logs, and regulatory databases.
Prepare periodic regulatory archival and compliance reports.
Process Excellence & Documentation
Prepare and maintain process maps, SOPs, work instructions, and regulatory guidance documents.
Support continuous improvement initiatives within the Regulatory Affairs function.
Ensure regulatory processes remain aligned with organizational quality standards and evolving regulatory requirements.
Electronic Dossier Validation – NeeS/eCTD
Validate NeeS and country-specific electronic submissions for structural and technical compliance.
Perform quality checks on hyperlinks, bookmarks, document naming conventions, and navigation functionality.
Ensure submission packages are technically compliant before dispatch to Health Authorities.
Regulatory Publishing & Submission Readiness
Review published regulatory dossiers and submission outputs.
Ensure submission packages meet Health Canada technical requirements.
Coordinate with publishing teams to achieve submission readiness within agreed timelines.
Support troubleshooting of publishing and technical submission issues.
Required Skills & Qualifications:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related scientific discipline.
Minimum 3 years of experience in Regulatory Affairs.
Experience in Regulatory Affairs activities related to the Canada market.
Experience in dossier preparation and review.
Knowledge of regulatory submissions and lifecycle management activities.
Hands-on experience with NeeS/eCTD submissions and regulatory publishing.
Strong understanding of Health Canada regulations and guidance documents.
Knowledge of regulatory strategy and dossier review.
Understanding of labeling and artwork compliance requirements.
Excellent documentation and regulatory record management skills.
Strong attention to detail and a quality-oriented mindset.
Excellent communication and stakeholder management skills.
Ability to manage multiple projects and meet tight regulatory timelines.
Key Skills:
Regulatory Affairs – Canada
Health Canada Regulations
Regulatory Strategy
Dossier Review
Module 1 Review
Regulatory Submissions
Lifecycle Management
Labeling & Artwork Compliance
NeeS / eCTD
Regulatory Publishing
Submission Readiness
Regulatory Documentation
Stakeholder Management
Quality & Compliance
Why Join Us:
Opportunity to work on Regulatory Affairs activities for the Canadian market.
Exposure to Health Canada regulatory requirements and submission processes.
Opportunity to work on dossier review, lifecycle management, labeling, and electronic submissions.
Work with cross-functional teams on regulatory projects.
Opportunity for professional development and career growth within Regulatory Affairs.
Apply
Interested candidates who meet the above requirements are encouraged to apply.
Minimum Experience Required: 3 Years
Location: Gurgaon, Haryana (India)
Apply via: career.ddreg.in