Senior Regulatory Affairs Associate

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 bodys 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.

Position Summary

Responsible for regulatory activities in support of assigned Therapeutic Dermatology Injectable Aesthetics and/or Dermatological Skincare business unit products including coordination of the preparation and review of regulatory submissions as well as serving on project teams.

This position is based at Galderma downtown Toronto office (161 Bay St.) with an annual salary range of 80000 - 95000 plus bonus.

Essential Functions

• Independently manages the preparation and review of regulatory submissions and responses for Therapeutic Dermatology Injectable Aesthetics and/or Dermatological Skincare business unit products. (i.e. NDS SNDS NC PDC DINA DINF CTA ITA NHP Cosmetic notification etc.)
• Develops and ensures execution of regulatory strategies to obtain timely approval from Health Canada.
• Reviews information related to adverse effects to assess risks and determine necessary actions such as updating drug labels or communicating potential risks to healthcare professionals and patients. Contribute to the preparation of pre-submission meeting packages if applicable.
• Responsible for the life-cycle management of marketed products and communication of regulatory requirements to cross-functional partners to maintain regulatory compliance.
• Works with manufacturing Quality Assurance and Global RA personnel to enable timely assessment and approval of new products and changes to marketed products.
• Reviews and approves change controls labeling promotional materials and other communications for Therapeutic Dermatology Injectable Aesthetics and/or Dermatological Skincare business unit products for compliance with applicable Health Canada regulations.
• Maintains up-to-date knowledge of Canadian HA regulations and keep abreast of new regulatory developments.
• Edit prepare and publish eCTD submissions for Canada
• Represents the Regulatory Affairs department on assigned project teams.
• Coordinates and manages Health Canada information requests and maintenance of internal databases and submission documents.
• Supports audits by Health Canada and/or other regulatory agencies as well as internal audits (e.g. Pharmacovigilance Quality)
• Helps mentor/train junior RA Staff if applicable
• Demonstrate honesty and integrity and model behaviors consistent with Galdermas Four Commitments company standards and policies.
• Demonstrate agility and adaptability in learning new technologies and business processes.
• Perform other related responsibilities as assigned to support departmental and organizational objectives.

Requirements

• 7 years of Canadian Regulatory Affairs experience is required.
• Bachelors degree required in science or related field.
• Knowledgeable of Health Canada laws and regulations of prescription drugs and devices as well as OTC drugs NHPs and cosmetics is required.
• Experience/Expertise with Plain Language Labelling for OTC and prescription drugs is required.
• Must be proficient with Microsoft Word and other common software tools.
• Must be experienced with or capable of learning how to use electronic review systems.
• Must have the ability to handle confidential information and materials in an appropriate manner and in accordance to organizational policy proper business practice and/or appropriate external regulation/governance.
• Excellent communication (verbal/written) interpersonal and organizational/ time management skills are required.
• A high level of integrity while working under pressure is required.
• Ability to function effectively with minimum supervision is required.
• Ability to identify problems collect data establish facts and draw valid conclusions.
• Employee must be able to multi-task and prioritize under pressure.