Job Description

Johnson & Johnson Innovative Medicine is recruiting for a Regulatory Affairs Associate, located in Toronto, Ontario, Canada, for a period of approximately 15 months.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 atFor 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 worldxe2x80x99s most pressing healthcare challenges.We know that the success of our business xe2x80x93 and our ability to deliver meaningful solutions xe2x80x93 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 Associate will support the regulatory activities to obtain and maintain product registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures. The Associate as a member of a team will help develop and implement regulatory strategies to meet project deliverables. As a subject matter authority for Regulatory Affairs the individual will provide guidance to local and global business partners.Key Responsibilities:

• Assist in the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Safety Supplements, and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products
• Assist in the preparation and review of responses to Health Canada queries (e.g. Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner
• Participate in interactions and assist in negotiations with Health Canada throughout the submission review cycle to ensure prompt regulatory approval and optimal labelling
• Work with global regulatory teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities
• Collaborate with internal stakeholder to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals/deadlines
• Support the resolution of emerging issues (e.g. new safety or quality finding) and the associated risk communications to stakeholders
• Provide regulatory guidance to internal business partner on messaging, promotional material review and PAAB responses
• Monitor the regulatory environment, interpret changes, analyze gaps and support the conduct of impact assessment, and participate in implementation into systems/processes
• Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment

QualificationsEducation:

• A minimum of a BSc degree in Biological or related sciences is required

Experience and Skills:Required:

• 1-3 years Regulatory Affairs pharmaceutical or related experience, which can include Regulatory Affairs certification
• Basic knowledge of the drug development process
• 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
• Understanding of the application of laws, regulations, guidances and policies to specific projects
• Ability to interpret and understand Regulations in the context of the scientific and commercial environment
• Good scientific writing skills
• Ability to interpret and summarize clinical data
• Problem solving and analytical skills
• Project management skills and ability to manage multiple priorities
• Good communication (oral and written) and strong interpersonal skills
• Negotiation and influencing skills
• Experience working within teams

Preferred:

• Experience in the oncology or immunology therapeutic area
• Experience in preparing therapeutic/labeling submissions
• Ability to interpret basic biostatistics

Other:

• Minimal travel required <5%

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 have the opportunity to achieve their potential.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson