Regulatory Affairs Manager

Job summary

Compile and manage regulatory dossiers and product registration filings for Canada, the UK/EU, and Australia, and support US filings as needed. Respond to agency queries, coordinate with stakeholders and global regulatory teams, and manage regulatory communications and meetings with Health Canada.

Job details

Purpose: This position will be responsible for regulatory product registration filings in key markets including Canada, UK/EU and AU and will need to support US filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from the regulatory agencies, and interacting with stakeholders. This position will also be responsible for managing regulatory communications with Health Canada. Position/Job Title: Manager Department: Regulatory Affairs Reporting To AGM/GM-Regulatory Affairs (Key Markets) Years of Experience: 5-7 years Work Location: Remote Job Responsibilities: Compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products. Responding to queries from regulatory agencies. Co-ordinate with stakeholders and cross-functional team for filing documents and data. Manage product registration filings in key markets. Manage communications with Health Canada. Manage meetings and discussions with Health Canada. Support as needed, US filings in the pre-approval or post approval space. Coordinate with global regulatory teams. Ensure business growth and operational excellence within regulatory set up. Qualifications: B.S/M.S in Pharmaceutical Sciences Proficiency in Regulatory Affairs. Knowledge about Pharmaceutical Product Development. Excellent communication, planning, analytical and interpersonal skills. Prior work experience with Health Canada is preferred.

What you’ll do

Compile and manage regulatory dossiers and product registration filings for Canada, the UK/EU, and Australia, and support US filings as needed. Respond to agency queries, coordinate with stakeholders and global regulatory teams, and manage regulatory communications and meetings with Health Canada.

Requirements

Requires 5–7 years of experience and a bachelor's or master's degree in Pharmaceutical Sciences, along with proficiency in Regulatory Affairs and knowledge of pharmaceutical product development. Excellent communication, planning, analytical, and interpersonal skills are required; prior experience with Health Canada is preferred.

Listed skills

• Cross-Functional Collaboration · Preferred
• Communication · Preferred
• Planning · Preferred
• interpersonal skills · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory Affairs
• Regulatory Product Registration
• Dossier Compilation
• Regulatory Filings
• Health Canada Communications
• Regulatory Agency Query Responses
• Stakeholder Coordination
• Cross-Functional Collaboration
• Pharmaceutical Product Development
• Global Regulatory Coordination
• Communication
• Planning
• Analytical Skills
• Interpersonal Skills

Job areas

• Healthcare
• Management & Leadership
• Science & Research
• Manufacturing

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