Senior Associate, Regulatory Affairs 12- Months Fixed Term Contract (Toronto, Ontario)

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.

As guided by Our Credo (https://www.jnj.com/our-credo) Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Thank you for your interest in J&J. As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. If you require any accommodation at any point in the recruitment process, please let us know and we will work with you in an effort to ensure that you are able to fully participate in the process.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

The anticipated base pay range for this position is :

Applicable Pay Range 107,550.00 - 157,550.00

Additional Description for Pay Transparency:

y •As applicable for the role - Under current guidelines, this position is eligible for a discretionary performance bonus. •The Company uses Artificial Intelligence in its assessment of applicants. •This job posting is for an existing position.