Janssen Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs, located in Toronto, Canada. Please Note: This role will align with the Flexible Working Model - 2 days remote and 3 days in the office.
At Janssen, we are dedicated to addressing and solving some of the most meaningful unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and metabolic and chronic diseases. Passionate about our dedication 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.ca for more information.
The Associate Director, Regulatory Affairs will be responsible for regulatory activities to obtain and maintain product registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures. Lead a team of individuals to support product registrations and serve as the subject matter expert for Regulatory Affairs and provide guidance to local and global business partners. Be accountable for the development and implementation of regulatory strategies to meet project deliverables. Support the development of a talent pipeline.
Principal Responsibilities:
- Lead and train regulatory professionals to achieve their regulatory goals and business deliverables.
- Contribute to the development of Regulatory Affairs talent pipeline through the selection and development of regulatory professionals.
- Conduct analysis and risk assessment of development projects, develop innovative regulatory strategies to meet business deliverables.
- Lead the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Notifiable Changes (NCs), and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products.
- Lead the preparation and review of responses to Health Canada queries (e.g., Clarifax, Notice of Non-Compliance (NON), and Notice of Deficiency (NOD)) in a timely manner.
- Lead interactions with Health Canada throughout the submission review cycle to ensure prompt regulatory approval, optimal labelling and implementation of local regulatory strategies.
- Collaborate with global regulatory teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities.
- Collaborate with internal stakeholders to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals/deadlines set out by the leadership team.
- Develop effective working relationships with experts to support regulatory strategies as needed.
- Manage emerging issues (e.g., new safety or quality finding) and associated risk communications to stakeholders.
- Provide regulatory guidance to internal stakeholders 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.
- Shape Health Canada policies to pave a favorable regulatory environment for pipeline products.
- Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment.
- Please Note: This role does not involve Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs.
- A minimum of a Master’s degree in Biological or related Science discipline. Advanced degree preferred.
- A minimum of 5 years of Regulatory Affairs pharmaceutical or related experience is required.
- People supervisory/leadership skills with the ability to work with and coach teams is required.
- Strong working knowledge of the drug development process is required.
- Strong knowledge of drug laws, regulations, guidelines and policies required.
- Knowledge of the Health Authority (HA) organizational structure and processes for the review and approval of drug submissions is required.
- Understanding of the application of laws, regulations, guidance and policies to specific projects/product needs preferred.
- Strong scientific writing skills required.
- Strong project management skills and ability to manage multiple priorities is required.
- Must have excellent communication (oral and written), interpersonal and negotiation skills.
- Must have strong problem-solving, analytical and strategic-thinking skills.
- Must excellent customer and marketplace focus.
- The ability to interpret and summarize clinical data is required.
- The ability to interpret and understand Regulations in the context of the scientific and commercial environment is required.
- The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.
- This position will require up to 10% 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 can achieve their potential.
