Manager, Regulatory Affairs (1 of 2)

Johnson & Johnson; Old Toronto; Hybrid; CAD 80,000 - 120,000; Full time

Job summary

An innovative firm is seeking a Regulatory Affairs Manager to oversee regulatory activities for drug product registration in compliance with Canadian laws. This role involves leading the preparation of regulatory submissions, collaborating with cross-functional teams, and mentoring interns. The ideal candidate will have a strong background in regulatory affairs, excellent scientific writing skills, and the ability to navigate complex regulatory environments. Join a company that values diversity and inclusion, where your contributions will significantly impact the healthcare landscape and support the development of life-saving products.

Qualifications

• Minimum 5 years in Regulatory Affairs or related experience.
• Strong knowledge of Canadian drug laws and regulations.

Responsibilities

• Develop regulatory strategic plans for product registration.
• Lead regulatory submissions and maintain product lifecycle.
• Collaborate with global teams for regulatory activities.

Skills

Regulatory Affairs

Drug Development Process

Scientific Writing

Problem Solving

Analytical Skills

Biostatistics Interpretation

Education

B.Sc. in Biological Sciences

MSc/PhD in related field

Job description

Job Description - Manager, Regulatory Affairs (1 of 2) (2406225395W)

Johnson & Johnson Innovative Medicine is recruiting for a Manager, Regulatory Affairs to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).

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).

Key Responsibilities:

• 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 on the clinical/therapeutic claims and not the Chemistry, Manufacturing and Controls.
• Lead 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]).
• Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling.
• Collaborate with global cross-functional 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.
• Develop effective working relationships with business partners and the authorities to support regulatory strategies.
• Manage emerging issues (e.g. new safety finding) and the associated risk communications.
• 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 the improvement of departmental processes and initiatives to enhance the internal work environment.
• Mentor and develop interns and/or direct reports as applicable.

Qualifications

Education:

• A minimum B.Sc. in Biological or related sciences. MSc/PhD preferred.

Experience and Skills:

Required:

• Minimum 5 years of pharmaceutical or medical device Regulatory Affairs or related experience.
• 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).
• Strong working knowledge of the drug development process.
• 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.
• Ability to interpret and understand Regulations in the context of the scientific and commercial environment.
• Strong scientific writing skills.
• Ability to interpret and summarize clinical data.
• Strong problem solving and analytical skills.

Preferred:

• Ability to interpret basic biostatistics and observational research methodologies.

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.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.