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Manager, Regulatory Affairs

4 months ago

Montréal, Canada Endo International Full time

At Paladin, we believe that flexibility can have a positive impact. That's why our employees have the power to choose when and where they are most productive and effective. If you are looking for an opportunity to work from home for a fast-paced organization, Paladin is the place for you

This position requires a presence at our office located in St-Laurent, Montreal, one day per week, depending on operational needs.

Position Summary

The Manager, Regulatory Affairs evolves in an environment where priorities are rapidly changing and must manage multiple projects simultaneously. He is responsible for the timely approval and regulatory maintenance of products. He participates to numerous regulatory projects while managing a team. He must be able to handle multiple priorities and projects, adapt to a changing environment and have the capacity to take action rapidly while dealing with ambiguity.

Reports To

Director, Regulatory Affairs

Specific Responsibilities
- Prepare high quality regulatory submissions for prescription and non-prescription drugs, natural health products, biologics and medical devices.
- Evaluate data (chemistry/manufacturing, clinical, non-clinical, labeling), prepare CTD summaries (clinical, non-clinical and CMC), author Product monographs/package inserts, design of labels.
- Liaise with Health Canada and partners during preparation and review of the submissions.
- Assemble and compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink).
- Ensure liaison with Health Canada for specific regulatory matters including preparation of meetings with the Agency.
- Ensure that the various databases and post-approval activities related to regulatory submissions are kept up-to-date according to departmental procedures.
- Ensure that daily regulatory activities related to product life cycle are in compliance with the Canadian regulations and all relevant guidelines and policies.
- Provide support with coaching and mentoring for direct reports.
- Review and manage the planning, preparation and coordination of direct reports submissions ensuring Health Canada standards and scheduled timelines are met.
- Strong project management skills and highly organized
- Proven management skills
- Ability to adapt to changing priorities
- Excellent communication and negotiation skills
- Ability to effectively work in a team environment / strong interpersonal skills
- Ability to work independently in a fast paced environment
- Strong problem solving skills
- Ability to understand regulatory issues and evaluate risk/requirements
- Good regulatory strategic thinking
- Good writing and communication skills in English
- Bilingual in both official languages (English and French)

Required
- M.Sc. in Life Sciences or DESS in drug development.
- Minimum of 5 years in the Canadian regulatory field within the pharmaceutical industry.
- Experience in the preparation of electronic submissions.
- Strong background in both fields: clinical and Chemistry, Manufacturing, Controls (CMC).
- Excellent knowledge in Canadian regulations/guidelines as well as ability to interpret policies and guidelines for pharmaceuticals, biologics, medical devices and Natural Health Products.
- Strong scientific knowledge.
- Strong Microsoft Office skills.
- Good knowledge of drug development process.

Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.