Manager, Regulatory Affairs

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 Manager, Regulatory Affairs position to be located in Toronto, Ontario 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 Manager is responsible for managing and leading 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.

As a subject matter expert and leader for Regulatory Affairs, the individual will provide guidance to local and global business partners.

This role may have direct report(s).

You will be responsible for:



* Developing and implementing regulatory strategic plans for product registration and lifecycle management.


* Leading the preparation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports to Health Canada, and maintain the life cycle of currently marketed products.

The focus of this role is on the clinical/therapeutic claims and not the Chemistry, Manufacturing and Controls.


* Leading the development and review of responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter (e.g.

Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]).


* Leading interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling.


* Collaborating with global cross-functional teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities.


* Collaborating with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business obje...