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Associate Director, Regulatory Affairs
1 month ago
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).
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.
**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, develop 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**:
- Minimum B.Sc. in Biological or related sciences.
- Advanced degree preferred.
- 5+ years Regulatory Affairs pharmaceutical or related experience is required.
- Strong working knowledge of the drug development process is required.
- 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 is required.
- 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.
- Well-defined problem solving and analytical skills is required.
- Well-developed project management skills and ability to manage multiple priorities is required.
- Excellent communication (oral and written) and strong interpersonal skills is required
- Strong negotiation and influencing skills is required.
- Well-developed team skills is required.
- Excellent customer and market place focus is required.
- Demonstrated ability to think strategically is required.
- People supervisory and coaching skills is required.
- Well-developed interpersonal and leadership skills to facilitate teamwork and problem-solving is required.
- This role is to be located in Toronto and will require up to 10% travel.
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.
