Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs, 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.
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.
The Associate Director, Regulatory Affairs will be responsible for supporting 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 member of a team, the Associate Director will help develop and implement regulatory strategies to meet project deliverables, both as a member of a team and in leading others.
Key Responsibilities: Lead and mentor a group of regulatory professionals to deliver business objectives in close collaboration with local and global teams.Support the building of a Regulatory Affairs talent pipeline through the selection and development of regulatory professionals.Conduct analysis and risk assessment of pipeline projects, developing successful regulatory strategies to meet business results.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.Manage 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 timely 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 partners to ensure alignment of regulatory affairs strategy with business priorities.Develop effective working relationships with opinion leaders as needed.Handle emerging issues (e.g., new safety or quality finding) and associated risk communications to stakeholders.Provide regulatory guidance to internal collaborators on messaging, promotional material review, and PAAB responses.Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessments.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. Qualifications: Education:
Minimum B.Sc.
in Biological or related sciences.
Advanced degree preferred.
Experience and Skills: Required:
5-8 years of Regulatory Affairs pharmaceutical or related experience.
Strong working knowledge of the drug development process.
Solid understanding of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions.
Understanding of the application of laws, regulations, guidances and policies to specific projects.
Ability to interpret and understand Regulations in the context of the scientific and commercial environment.
Ability to interpret, summarize and communicate clinical data.
Well-defined problem solving and analytical skills.
Well-developed project management skills and ability to manage multiple priorities.
Excellent communication (oral and written).
Strong negotiation and influencing skills.
Well-developed team skills.
Excellent customer and market place focus.
Demonstrated ability to think strategically.
People supervisory and coaching skills.
Well-developed interpersonal and leadership skills to facilitate teamwork and problem-solving.
Preferred:
Previous people manager experience preferred.
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.
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