Manager, Regulatory Affairs

at  Johnson Johnson

Johnson & Johnson Innovative Medicine is recruiting for a Regulatory Affairs Manager to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
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

• A minimum B.Sc. in Biological or related sciences. MSc/PhD preferred.
• 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) 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.
• Experience in the oncology therapeutic area is desirable.
• 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.
• Ability to interpret basic biostatistics and observational research methodologies is highly desirable.
• Strong problem solving and analytical skills is required.
• This position is to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).
  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.
  For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com
  This job posting is anticipated to close on 8/15/24. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications

• 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 applicabl