Experience Inc. Jobs

Regulatory Affairs Intern - 2406208337W

Description

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/.

Johnson & Johnson Innovative Medicine in Canada is currently recruiting for a Regulatory Affairs Intern to be located in Toronto, Ontario, Canada under the flexible working model (2 days remote 3 days in office).

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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.

In this role, you will:

• 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 departments effort to operationalize and improve critical departmental processes.

Qualifications

• The applicant will have a Bachelors degree in the biological or life sciences. An advanced university degree (MSc, PhD) in biological sciences or life sciences is preferred.

• Enrolled in a Post Graduate Certificate or Degree program related to Regulatory Affairs.

• 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 is highly desirable.

• The ability to interpret and summarize Real World Evidence is highly desirable.

• The ability to interpret basic biostatistics is highly desirable.

• This position is located in Toronto, Ontario.

• This position duration is 12 months.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location NA-CA-Ontario-Toronto

Organization Janssen Inc. (7710)

Job Function Non-LDP Intern/Co-Op

Req ID: 2406208337W