Manager, Regulatory Affairs (2 positions)

Johnson & Johnson; Toronto; Hybrid; CAD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager to lead regulatory activities for drug product registration in Toronto. This role involves developing strategic regulatory plans, managing submissions, and collaborating with global teams to ensure compliance with Canadian drug laws. The ideal candidate will have extensive experience in regulatory affairs, strong scientific writing skills, and a deep understanding of the drug development process. Join a dynamic team committed to innovation and patient care, and make a significant impact on healthcare solutions.

Qualifications

• 5+ years of experience in pharmaceutical Regulatory Affairs.
• Strong knowledge of Canadian drug laws and regulations.

Responsibilities

• Manage regulatory activities for drug product registration.
• Lead preparation of regulatory submissions to Health Canada.

Skills

Regulatory Affairs

Clinical Data Interpretation

Scientific Writing

Problem Solving

Analytical Skills

Education

B.Sc. in Biological Sciences

MSc/PhD in Biological Sciences

Job description

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 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.

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