Manager, Regulatory Affairs

**Function**
- Regulatory Affairs Group

**Sub function**
- Regulatory Affairs

**Category**
- Manager, Regulatory Affairs (P7)

**Location**
- Toronto / Canada

**Date posted**
- May 30 2025

**Requisition number**
- R-007156

**Work pattern**
- Hybrid Work

Description

**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.

**Purpose**:
**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 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 objectives and stretch goals.
- Developing effective working relationships with business partners and the authorities to support regulatory strategies.
- Managing emerging issues (e.g. new safety finding) and the associated risk communications.
- Providing regulatory guidance and input to internal partners on messaging, promotional material review, and PAAB responses.
- Monitoring the regulatory environment, interpreting changes, analyzing gaps and conducting impact assessment, and participating/leading implementation into systems/processes.
- Actively contributing to the improvement of departmental processes and initiatives to enhance the internal work environment.
- Mentoring and developing interns and/or directing reports as applicable.

**Qualifications/ Requirements**:

- A minimum B.Sc. in Biological or related sciences is required. MSc/PhD preferred.
- Minimum 5 years of pharmaceutical Regulatory Affairs or related experience is required.
- Experience with the preparation and approval of regulatory submissions for brand name prescription drugs to a major Regulatory Authority (e.g. Health Canada, FDA, EMA, MHRA, TGA, SwissMedic) is required.
- Must have experience in clinical and therapeutic aspects of submissions is required.
- Strong working knowledge of the drug development process is required.
- 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 is required.
- Ability to interpret and understand Regulations in the context of the scientific and commercial environment is required.
- Strong scientific writing skills is required.
- Ability to interpret and summarize clinical data is required.
- Strong problem solving and analytical skills is required.
- Ability to interpret basic biostatistics and observational research methodologies is preferred.

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.

LI-Hybrid