Regulatory Affairs Associate (Fixed Term Employee Contract)

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 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 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 qual...