Regulatory Affairs Associate

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

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Toronto, Ontario, Canada

Job Description:

We are searching for the best talent for our Regulatory Affairs Associate position, located in Toronto, Ontario, Canada, under the flexible working model (at least 3 days in office).

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Purpose: 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.

You will be responsible to:



* 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 partners 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 collaborators


* Provide regulatory guidance to internal busi...