Janssen Inc., a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, is currently recruiting for a Senior Regulatory Affairs Associate to be located in Toronto, Ontario, to work primarily in the oncology / hematology therapeutic area.
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, metabolic and chronic diseases and women’s health. Motivated by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Please visit www.janssen.com/canada for more information.
The Senior Regulatory Affairs Associate is 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. As a subject matter authority for Regulatory Affairs, the individual will provide guidance to local and global business partners.
In this role, you will:
- Develop and implement regulatory strategies to meet project deliverables
- 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. This role is responsible for submissions in support of therapeutic product claims.
- Manage the development 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.
- Manage in partnership with Director, Regulatory Affairs critical interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling
- Work 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/deadlines set out by the leadership team.
- Develop effective working relationships with business partners and the authorities to support regulatory strategies as needed.
- Address key emerging issues (e.g. new safety or quality finding) and the associated risk communications.
- Provide regulatory guidance 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.
- Participate in the improvement of critical departmental processes and initiatives to enhance the internal work environment.
- A minimum Bachelors of Science in Biological or related sciences. Bachelor’s in Molecular/Cell biology an asset. Advanced degree preferred.
- Minimum 5 years (with Bachelor of Science) or 3 years (with advanced degree) of pharmaceutical or medical device Regulatory Affairs or related experience is required, which can include Regulatory Affairs certification.
- 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.
- Experience in the oncology/hematology therapeutic area is desirable.
- Experience preparing therapeutic/labeling submissions is desirable.
- Ability to interpret and understand Regulations in the context of the scientific and commercial environment is required.
- Good scientific writing skills is required.
- Ability to interpret and summarize clinical data is required.
- Problem solving and analytical skills is required.
- This position is located in Toronto, Ontario and will require up to 10% travel.
Diversity and inclusion are central elements of the shared culture at Johnson & Johnson. 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.
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.
Janssen Inc. (7710)