Manager, Regulatory Affairs

Janssen Inc., member of the Janssen Pharmaceutical Companies of Johnson & Johnson, is currently hiring for a Manager, Regulatory Affairs located in Toronto, Ontario.

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension and metabolic and chronic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com/canada for more information.

The Regulatory Affairs Manager will lead 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 Regulatory Affairs Manager will serve as the subject matter authority for Regulatory Affairs and provide guidance to local and global business partners. The Manager will develop and implement regulatory strategies to meet project results.

In this role, you will:

• Develop and implement regulatory strategic plans for product registration and lifecycle management.
• Lead 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 clinical/therapeutic not CMC).
• Lead the preparation and review of responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter (e.g. Clarification letters, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner.
• Lead interactions with Health Canada from pre-submission and throughout the submission review cycle to ensure prompt regulatory approval, optimal labeling and implementation of local regulatory strategies.
• Collaborate with 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 deadlines.
• Develop effective working relationships with business partners, clinical professionals and federal/provincial authorities to support regulatory strategies as needed.
• Manage emerging issues (e.g. new safety finding) and associated risk communications to partners.
• Provide regulatory guidance and input to internal partners on messaging, promotional material review, and PAAB responses.
• Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessment, and participate/lead implementation into systems/processes.
• Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment.
• Provide guidance to and mentor junior team members.

Qualifications

• A BSc with minimum 6 years of experience with pharmaceutical Regulatory Affairs or related experience OR A MSc/PhD with minimum 4 years of experience with 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.
• Experience in one or more of the following therapeutic areas is highly desirable: pulmonary hypertension, vaccines, immunology, oncology, anti-infectives, advanced therapeutic products, or neuroscience.
• Strong working knowledge of the drug development process is required.
• Strong 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 highly desirable.
• Ability to interpret and understand Regulations in the context of the scientific and commercial environment is highly desirable.
• Strong scientific writing skills are required.
• Ability to interpret and summarize clinical data is required.
• Ability to interpret and summarize Real World Evidence is highly desirable
• Ability to interpret basic biostatistics and observational research methodologies highly desirable.
• Strong problem solving and analytical skills
• This position is to be located in Toronto, Ontario and will require up to 10% domestic and international travel.

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.

Primary Location
Canada-Ontario-Toronto-19 Green Belt Drive
Organization
Janssen Inc. (7710)
Job Function
Regulatory Affairs
Requisition ID
2105961053W