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About the Role

Responsible for regulatory activities supporting assigned Therapeutic Dermatology, Injectable Aesthetics, and/or Dermatological Skincare products. This includes coordinating the preparation and review of regulatory submissions and serving on project teams.

Responsibilities

• Independently manages the preparation and review of regulatory submissions and responses for assigned business unit products.
• Develops and ensures execution of regulatory strategies to obtain timely approval from Health Canada.
• Reviews adverse effect information to assess risks and determine necessary actions.
• Contributes to the preparation of pre-submission meeting packages.
• Responsible for the life-cycle management of marketed products.
• Communicates regulatory requirements to cross-functional partners to maintain compliance.
• Works with manufacturing, Quality Assurance, and Global RA personnel to enable timely assessment and approval of products and changes.
• Reviews and approves change controls, labeling, promotional materials, and other communications for compliance with Health Canada regulations.
• Maintains up-to-date knowledge of Canadian HA regulations and new regulatory developments.
• Edits, prepares, and publishes eCTD submissions for Canada.
• Represents the Regulatory Affairs department on assigned project teams.
• Coordinates and manages Health Canada information requests and maintains internal databases and submission documents.
• Supports audits by Health Canada, other regulatory agencies, and internal audits.
• Helps mentor/train junior RA Staff, if applicable.
• Demonstrates honesty, integrity, and behaviors consistent with company standards and policies.
• Demonstrates agility and adaptability in learning new technologies and business processes.
• Performs other related responsibilities as assigned.

Requirements

• 7+ years of Canadian Regulatory Affairs experience required.
• Proficient with Microsoft Word and other common software tools.
• Experienced with, or capable of learning how to use, electronic review systems.
• Ability to handle confidential information appropriately.
• Excellent communication (verbal/written), interpersonal, and organizational/time management skills required.
• High level of integrity while working under pressure required.
• Ability to function effectively with minimum supervision required.
• Ability to identify problems, collect data, establish facts, and draw valid conclusions.
• Ability to multi-task and prioritize under pressure.

Skills

• Plain Language Labelling for OTC and prescription drugs

Location

• Toronto, ON

Work Type

• Onsite

Experience Level

• 7+ years

Education Level

• Bachelor's degree in science or related field

Salary/Compensations

• 80,000 - 95,000 plus bonus

About the Company

• Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries.
• We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.
• Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.
• Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story.
• We look for people who focus on getting results, embrace learning and bring a positive energy.
• They must combine initiative with a sense of teamwork and collaboration.
• Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.
• We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future.
• Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
• At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world.
• With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.