Senior Regulatory Affairs Associate

Galderma•Toronto, ON

3d•CA$80,000 - CA$95,000•Onsite

About The Position

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 80,000 - 95,000 plus bonus.

Requirements

7+ years of Canadian Regulatory Affairs experience is required.
Bachelor’s 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.

Responsibilities

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 Galderma’s 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.