Regulatory Affairs Manager

Ethypharm; Montreal; On-site; CAD 80,000 - 100,000; Full time

Job summary

A pharmaceutical company is seeking a Regulatory Affairs Manager for its North American operations in Montreal. The role involves ensuring compliance with US and Canadian regulations, overseeing product dossiers, and collaborating across departments. Ideal candidates will have a degree in a health-related discipline, 3-5 years of relevant experience, and fluency in English and French.

Qualifications

• 3-5 years’ experience in a pharmaceutical regulatory affairs environment.
• Practical knowledge of FDA, Health Canada, and ICH regulations.

Responsibilities

• Assemble NDAs / ANDAs and other regulatory filings.
• Serve as regulatory contact point for North American partners.
• Participate in audits and compliance monitoring.

Skills

Fluent in English

Fluent in French

Attention to detail

Ability to work under tight deadlines

Ability to interpret regulatory guidelines

Education

B.A., B.S. Degree in Science in health-related discipline or Pharm.D. Degree

Job description

Direct message the job poster from Ethypharm

Head of HR, Group and Commercial, Ethypharm

Ethypharm, a European pharmaceutical group focused on Pain, Addiction and Critical care is looking for a Regulatory Affairs Manager for its North American subsidiary based in Montreal.

Within the Pharmaceutical & Medical Affairs direction, and more specifically in the Corporate Regulatory Affairs Department, you will be the representative of Corporate Regulatory Affairs for products aimed to the North American market.

You will ensure compliance with US and Canadian regulatory requirements and maintenance of the Ethypharm marketed products dossiers.

You will be also the contact point for the regulatory affairs of the US and Canadian licensees who market our products under licence.

You will work in close collaboration with the European Regulatory Affairs Department and other teams (such as QA, industrial, development, purchase…) in Europe.

This position will be based in Montréal, Canada.

Your responsibilities :

• Participates to the assembly of the NDAs / ANDAs, NDS and other regulatory filings such as CMC and Labeling post approval submissions.
• Be the regulatory contact point for US and Canadian partners who market our products in North America.
• Participates in audits and inspections of North American affiliate by internal auditor or Health authorities.
• Maintains high level of knowledge of US and Canadian Regulations.
• Monitors and ensures compliance to specific administrative regulation in the countries of reference : GDUFA, Establishment Registration, Drug Listing, DEL, MDEL etc.
• Participates in the creation and review of local Standard Operating Procedure related to regulatory activities.

Your professional profile :

• You have a B.A., B.S. Degree in Science in health-related discipline or Pharm.D. Degree with 3-5 years’ experience in a pharmaceutical regulatory affairs environment.
• You have a practical knowledge and are able to interpret the Federal laws, regulations (FDA, Health Canada and ICH), guidelines, policies and procedures related to drug development, registration, and post marketing follow-up.

Your personal profile :

• Well organized with attention to detail
• Able to provide support and direction to others
• Windows-based environment
• Ability to work well with various departments and people
• Must be able to work with minimal supervision
• Must work well under tight deadlines
• English & French fluent, Spanish language is a plus.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Other

Pharmaceutical Manufacturing

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