Regulatory Affairs Intern - Toronto, Canada - Johnson & Johnson

Johnson & Johnson

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

At Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world's the most significant healthcare challenges.

Our Corporate, Consumer Health, Medical Devices, and Pharmaceutical teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines.

We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives.

With a reach of more than a billion people every day, there's no limit to the impact you can make here.

Are you ready to reimagine healthcare? Here, your career breakthroughs will change the future of health, in all the best ways.

And you'll change, too.

You'll be inspired, and you'll inspire people across the world to change how they care for themselves and those they love.

Amplify your impact. Join us

Janssen Inc.

is recruiting for a
Regulatory Affairs Intern , located in Toronto, Ontario, with a preferred start date of
January 2023 .

We offer a work culture that is open, creative, and performance driven with an environment that is fun and sophisticated.

Within our facilities we have a fitness center that you can access and an online company store, exclusive to employees, where you can purchase J&J products.

We also offer opportunities for employees to get involved in sports teams, social events and to volunteer with local charities.

The Regulatory Affairs department is responsible for the registration of new pharmaceutical products, new product indications and line extensions and for compliance with Health Canada regulatory requirements for drug products.

Key Responsibilities:

Assist in the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and other submissions to support the lifecycle management of pharmaceutical products. The focus of this role is clinical/therapeutic not CMC.
Collaborate with internal partners to ensure delivery of regulatory affairs activities to meet strategic business objectives and goals.
Assist with the department's effort to operationalize and improve critical departmental processes.

Qualifications:

Education:

The applicant has a Bachelor's degree in biological or life sciences.
Pursuing a Post Graduate Regulatory Affairs Certificate (Hons. Standing) and/or an advanced university degree (MSc, PhD) in biological or life sciences.

Experience and Skills:

Required:

Strong computer skills. Knowledge of databases and Excel.
Strong problemsolving and analytical skills.
Strong teamwork and communication skills (oral and written). Scientific writing skill highly desirable.
Project management skills and ability to handle multiple priorities
Knowledge of the drug development process is highly desirable.
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 highly desirable.
The ability to interpret and summarize clinical data is highly desirable.
The ability to interpret and summarize Real World Evidence is highly desirable.
The ability to interpret basic biostatistics is highly desirable.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies.

Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success.

We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.