Senior Associate, Regulatory Affairs 12- Months Fixed Term Contract (Toronto, Ontario)
About The Position
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. We are searching for the best talent for a Senior Associate, Regulatory Affairs 12-month Fixed Term Contract located in Toronto, Ontario. This Senior Associate, Regulatory Affairs 12- month Fixed Employee Contract is responsible for supporting the regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations, as well as corporate policies and procedures. As a subject matter authority for Regulatory Affairs, the individual will provide guidance to local and global business partners.
Requirements
- A minimum B.Sc. in Biological or related sciences. MSc/PhD preferred.
- Minimum 4 years (with B.Sc.) or 2 years (with MSc/PhD) of pharmaceutical or medical device Regulatory Affairs or related experience is required, which can include Regulatory Affairs certification.
- Knowledge of the drug development process is required.
- Knowledge of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions is required.
- Ability to interpret and understand Regulations in the context of the scientific and commercial environment.
- Good scientific writing skills.
- Ability to interpret and summarize clinical data.
- Strong problem solving and analytical skills.
Nice To Haves
- Experience preparing therapeutic/labeling submissions is desirable.
- Ability to interpret basic biostatistics and observational research methodologies is highly desirable.
Responsibilities
- Develop and implement regulatory strategic plans for product registration and lifecycle management
- Manage the preparation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports to Health Canada, and maintain the life cycle of currently marketed products. The focus of this role is on the clinical/therapeutic claims and not the Chemistry, Manufacturing and Controls.
- Manage the development and review of responses to Health Canada queries (e.g. Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner.
- Lead in partnership with Director, Regulatory Affairs interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling
- Work with global cross-functional teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities.
- Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals
- Develop effective working relationships with business partners and the authorities to support regulatory strategies.
- Address key emerging issues (e.g. new safety or quality finding) and the associated risk communications.
- Provide regulatory guidance to internal partners on messaging, promotional material review, and PAAB responses.
- Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessment, and participate/lead implementation into systems/processes.
- Participate in the improvement of departmental processes and initiatives to enhance the internal work environment.
Benefits
- As applicable for the role - Under current guidelines, this position is eligible for a discretionary performance bonus.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
