Regulatory Affairs Associate (12 month contract)

at  Johnson Johnson

Johnson & Johnson Innovative Medicine is currently recruiting for a Regulatory Affairs Associate, one of two roles, (12-month contract) to be located in Toronto, Ontario, Canada under the flexible working model (at least 3 days in office).
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/
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 world’s 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 Associate will be responsible for supporting the regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug 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.

In this role, you will:

• Assist in the preparation and compilation of regulatory submissions including New Drug Submissions, Supplemental New Drug Submissions, 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, and Notice of Deficiency) in a timely manner.
• Participate in interactions and assist in negotiations with Health Canada from pre-submission and throughout the submission review cycle to ensure timely regulatory approval, optimal labelling, and implementation of local regulatory strategies.
• Work with cross-functional teams and the Global Regulatory Affairs function/teams to facilitate regulatory activities.
• Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals.
• Support the resolution of emerging issues (e.g. new safety or quality finding) and the associated risk communications to stakeholders.
• Develop effective working relationships with business partners and the authorities to support regulatory strategies.
• Provide regulatory guidance to internal partners 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 departmental processes and initiatives to enhance the internal work environment.

QUALIFICATIONS

• A minimum B.Sc. in Biological or related sciences. MSc/PhD preferred.
• Minimum 1+ years of pharmaceutical or medical device Regulatory Affairs or related experience, which can include Regulatory Affairs certification.
• 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.
• Experience preparing therapeutic/labeling submissions is desirable.
• 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.
• Ability to interpret basic biostatistics.
• Strong problem solving and analytical skills.
• This position is located in Toronto, Ontario and will require up to 5% travel.
  At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love.
  Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefit

• Assist in the preparation and compilation of regulatory submissions including New Drug Submissions, Supplemental New Drug Submissions, 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, and Notice of Deficiency) in a timely manner.
• Participate in interactions and assist in negotiations with Health Canada from pre-submission and throughout the submission review cycle to ensure timely regulatory approval, optimal labelling, and implementation of local regulatory strategies.
• Work with cross-functional teams and the Global Regulatory Affairs function/teams to facilitate regulatory activities.
• Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals.
• Support the resolution of emerging issues (e.g. new safety or quality finding) and the associated risk communications to stakeholders.
• Develop effective working relationships with business partners and the authorities to support regulatory strategies.
• Provide regulatory guidance to internal partners 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 departmental processes and initiatives to enhance the internal work environment