Senior Associate, Regulatory Affairs (18-Month Fixed Employee Contract)

Johnson & Johnson; Toronto; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading healthcare company is seeking a Senior Associate in Regulatory Affairs in Toronto. The role involves developing regulatory strategies, managing submissions, and collaborating with internal and external partners. Candidates should possess a B.Sc. in Biological sciences and have relevant experience in regulatory affairs. This position may require up to 10% travel and offers a fixed-term contract.

Qualifications

• Minimum 4 years of pharmaceutical or medical device Regulatory Affairs experience.
• Knowledge of Canadian drug laws and regulations required.
• Experience preparing therapeutic / labeling submissions is desirable.

Responsibilities

• Develop and implement regulatory strategic plans for product registration.
• Manage preparation of regulatory submissions to Health Canada.
• Lead interactions with Health Canada for timely regulatory approval.

Skills

Good scientific writing skills

Strong problem solving skills

Ability to interpret and summarize clinical data

Knowledge of drug development process

Ability to interpret Regulations

Education

B.Sc. in Biological or related sciences

MSc / PhD preferred

Job description

Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Details

Location: Toronto, Ontario, Canada

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

Position: Senior Associate, Regulatory Affairs (18-month Fixed Employee Contract)

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

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.

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.
• Experience preparing therapeutic / labeling submissions is desirable.
• 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.
• Ability to interpret basic biostatistics and observational research methodologies is highly desirable.
• Strong problem solving and analytical skills.
• This position is located in Toronto, Ontario and will require up to 10% travel.