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

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 Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations:

Toronto, Ontario, Canada

Job Description

We are searching for the best talent for a Senior Associate, Regulatory Affairs (18-month Fixed Employee Contract) located in Toronto, Ontario.

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

This Senior Associate, Regulatory Affairs (18- 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.

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.