REGULATORY AFFAIRS INTERN

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.
nj.
om/.
Janssen Inc.
is currently recruiting for a Regulatory Affairs Intern to be located at 19 Green Belt Drive in Toronto, Ontario.
This position will work closely with various members of the Regulatory Affairs team, reporting to a Regulatory Affairs Manager.  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.  Your role as Regulatory Affairs intern will include the following responsibilities:  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.
Under supervision, may assist in tasks supporting regulatory submissions.
Qualifications The applicant will have a Bachelor’s degree in the biological or life sciences.
Pursuing a Post Graduate Regulatory Affairs Certificate Strong computer skills.
Knowledge of databases and Excel.
Strong problem-solving 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.
IDEAL REQUIREMENTS  An advanced university degree (MSc, PhD) in biological sciences or life sciences is preferred.
Scientific writing skill highly desirable.
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.  Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.