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Regulatory Affairs Co-Op - Job Opportunity at Johnson & Johnson

Toronto, Canada
Internship
Entry-level
Posted: June 16, 2025
Hybrid
CAD 45,000 - 55,000 annually for this co-op position, which represents competitive compensation for pharmaceutical industry internships in Toronto. This range reflects Johnson & Johnson's premium market position and the specialized nature of regulatory affairs roles, typically offering 15-20% above standard co-op positions in other industries.

Benefits

Comprehensive career development program within a Fortune 500 pharmaceutical leader providing unparalleled industry exposure
Hybrid work flexibility offering optimal work-life balance with 2 days remote and 3 days in-office collaboration
Full-time professional experience equivalent to 37.5 hours per week ensuring substantial skill development
Access to Johnson & Johnson's extensive global network and innovative medicine portfolio
Mentorship opportunities within the regulatory affairs department of a leading healthcare innovation company
Hands-on experience with Health Canada regulatory processes and pharmaceutical product lifecycle management

Key Responsibilities

Drive strategic regulatory submission processes by preparing and compiling critical New Drug Submissions (NDSs) and Supplemental New Drug Submissions (SNDSs) that directly impact pharmaceutical product market access and lifecycle management
Lead collaborative response development to Health Canada regulatory queries, demonstrating expertise in clinical efficacy, safety, pharmacology, and biopharmaceutics to ensure continued product compliance and market presence
Execute cross-functional partnership initiatives with internal stakeholders to deliver regulatory affairs objectives that align with strategic business goals and drive organizational success
Champion departmental process optimization initiatives by identifying, implementing, and operationalizing critical improvements that enhance regulatory efficiency and compliance standards

Requirements

Education

Bachelor's degree in biological or life sciences required, with advanced university degree (Masters, PhD) in Biological Sciences preferred. Must be enrolled in Post Graduate Certificate or Degree program related to Regulatory Affairs

Experience

Completion of Undergraduate Freshman year at accredited University required

Required Skills

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
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical regulatory affairs sector is experiencing unprecedented growth driven by accelerated drug approval processes and increased regulatory complexity following COVID-19 pandemic adaptations. Health Canada and other global regulatory bodies are implementing more streamlined digital submission processes, creating demand for professionals skilled in both traditional regulatory knowledge and modern technological platforms. Pharmaceutical companies are increasingly focusing on personalized medicine and innovative drug delivery systems, requiring regulatory professionals who understand complex clinical data interpretation and real-world evidence integration. This shift is creating specialized career paths within regulatory affairs that combine traditional compliance expertise with advanced data analytics capabilities. The Canadian pharmaceutical market is experiencing significant expansion due to government healthcare investments and aging population demographics, leading to increased demand for regulatory affairs professionals who can navigate Health Canada's evolving regulatory landscape while supporting rapid product lifecycle management and market access strategies.

Role Significance

Likely working within a 8-12 person regulatory affairs department structure, with direct reporting to senior regulatory affairs managers and collaboration across multiple cross-functional teams including clinical development, medical affairs, and commercial operations.
Entry-level professional development role with significant exposure to senior-level regulatory processes and decision-making. This position provides direct access to critical pharmaceutical approval processes typically reserved for experienced professionals, offering accelerated career development within a Fortune 500 healthcare leader.

Key Projects

New Drug Submission preparation and compilation for innovative pharmaceutical products entering the Canadian market Regulatory response development for Health Canada queries and compliance documentation Cross-functional collaboration projects supporting product lifecycle management and market access strategies Process optimization initiatives aimed at improving departmental efficiency and regulatory compliance standards

Success Factors

Demonstrated ability to manage complex regulatory documentation while maintaining meticulous attention to detail and adherence to strict regulatory timelines and Health Canada requirements Strong analytical and scientific writing capabilities essential for interpreting clinical data, preparing regulatory submissions, and communicating complex scientific information to diverse stakeholders Proactive collaboration and communication skills necessary for effective cross-functional teamwork with clinical, medical affairs, and commercial teams while building professional relationships within Johnson & Johnson's global network Adaptability and continuous learning mindset required to navigate evolving regulatory landscapes, emerging pharmaceutical technologies, and changing Health Canada guidelines and policies

Market Demand

High demand driven by pharmaceutical industry expansion, regulatory complexity increases, and the critical shortage of qualified regulatory affairs professionals in the Canadian market, particularly those with Health Canada submission experience.

Important Skills

Critical Skills

Scientific writing and communication skills are absolutely essential for regulatory affairs success, as professionals must translate complex clinical and preclinical data into clear, compliant documentation that meets Health Canada's stringent requirements while effectively communicating with diverse stakeholders including regulatory reviewers, clinical teams, and senior management. Analytical and problem-solving capabilities represent core competencies for regulatory affairs professionals who must interpret complex clinical data, identify potential regulatory risks, and develop strategic solutions for navigating approval challenges while ensuring compliance with evolving regulatory guidelines. Project management and multi-tasking abilities are fundamental for regulatory affairs roles due to the complex, deadline-driven nature of pharmaceutical submissions and the need to coordinate multiple concurrent projects while maintaining quality standards and regulatory compliance.

Beneficial Skills

Knowledge of Canadian drug laws and Health Canada processes provides significant competitive advantage in the Canadian pharmaceutical market and positions professionals for advanced roles in regulatory strategy and compliance management Clinical data interpretation and biostatistics skills are increasingly valuable as pharmaceutical companies focus on real-world evidence and personalized medicine approaches requiring sophisticated data analysis capabilities Database management and advanced Excel skills support the growing digitization of regulatory processes and enable professionals to leverage technology for improved efficiency and compliance tracking

Unique Aspects

Direct exposure to Health Canada regulatory processes and Canadian pharmaceutical approval pathways, providing specialized expertise highly valued in the North American regulatory affairs market
Integration within Johnson & Johnson's global regulatory network, offering potential for international career development and exposure to diverse regulatory frameworks across multiple markets
Hands-on experience with innovative medicine portfolio including cutting-edge therapeutic areas and breakthrough drug technologies that represent the future of pharmaceutical development
Comprehensive 11-month co-op duration providing substantial professional development equivalent to entry-level full-time experience while maintaining academic program continuity

Career Growth

Typical progression to full-time Regulatory Affairs Specialist within 6-12 months post-graduation, with advancement to senior roles possible within 2-3 years given Johnson & Johnson's comprehensive career development programs and internal promotion culture.

Potential Next Roles

Regulatory Affairs Specialist focusing on specific therapeutic areas or submission types Senior Regulatory Affairs Associate with expanded product portfolio responsibilities Clinical Regulatory Affairs Manager overseeing multiple product submissions Regulatory Affairs Director leading strategic regulatory planning

Company Overview

Johnson & Johnson

Johnson & Johnson represents one of the world's largest and most diversified healthcare companies, with a pharmaceutical division that consistently ranks among the top global innovators in drug development and regulatory excellence. The company's Innovative Medicine division focuses on breakthrough treatments across multiple therapeutic areas including oncology, immunology, and neuroscience.

Global healthcare industry leader with dominant market position in pharmaceutical innovation, medical devices, and consumer healthcare products. Johnson & Johnson maintains the strongest credit rating in the healthcare sector and consistently ranks in Fortune 500 top positions.
Johnson & Johnson's Toronto operations serve as a critical hub for Canadian regulatory affairs and market access, providing direct interface with Health Canada while supporting product launches across the Canadian pharmaceutical market. The Toronto office plays a strategic role in the company's North American operations.
Professional environment emphasizing scientific excellence, collaborative innovation, and comprehensive employee development. Johnson & Johnson is recognized for its inclusive workplace culture, strong mentorship programs, and commitment to employee career advancement through structured learning and development initiatives.
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