Regulatory Affairs Co-Op

Descrizione del lavoro:

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 jnj.com
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. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Career Programs
Job Sub Function: Non-LDP Intern/Co-Op
Job Category:Career Program
All Job Posting Locations:Toronto, Ontario, Canada
Job Description:

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
We are searching for the best talent for Regulatory Affairs Co-Op to be in Toronto, ON.
* The Co-op term is from July, 2026 to June, 2027.
* Full time requirement (37,5 hours per week).
* Flexible working model (2 days remote / 3 days in office).

Purpose:

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.

You will be responsible:

* 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.
* Assist in the development of responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter (e.g. Clarification letters, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner.
* 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 / Requirements:

* Completion of Undergraduate Freshman year at an accredited University is required.
* The applicant will have a Bachelor's degree in the biological or life sciences. An advanced university degree (Masters, PhD) in Biological Sciences (Therapeutic, Clinical, Pharmacology or related fields) is preferred.
* Enrolled in a Post Graduate Certificate or Degree program related to Regulatory Affairs.
* Minimum GPA of 2.8 is required.
* Legally authorized to work in Canada.
* 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.
* 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, summarize Real World Evidence and basic biostatistics is highly desirable.
The base pay for this position is Second Year $26.00/hr, Third Year $27.50/hr, Fourth Year $28.50/hr, Post-graduate degree $32.00/hr.
The compensation and benefits information set forth in this posting applies to candidates hired in Canada. Candidates hired outside Canada (From US) will be eligible for compensation and benefits in accordance with their local market. The Company uses AI in its assessment of applicants. This job posting is for an existing position.
Ineligibility for severance.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :$26.00/hr to $32.00/hr
Additional Description for Pay Transparency:The base pay for this position is Second Year $26.00/hr, Third Year $27.50/hr, Fourth Year $28.50/hr, Post-graduate degree $32.00/hr. The compensation and benefits information set forth in this posting applies to candidates hired in Canada. Candidates hired outside Canada (From US) will be eligible for compensation and benefits in accordance with their local market. The Company uses AI in its assessment of applicants. This job posting is for an existing position