Regulatory Affairs Associate

2 months ago

Toronto, Canada Johnson & Johnson Full time

Johnson & Johnson Innovative Medicine is recruiting for a Regulatory Affairs Associate, located in Toronto, Ontario, Canada, for a period of approximately 15 months.

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:

- Assist in the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Safety Supplements, and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products
- Assist in 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
- Participate in interactions and assist in negotiations with Health Canada throughout the submission review cycle to ensure prompt regulatory approval and optimal labelling
- Work with global regulatory teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities
- Collaborate with internal stakeholder to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals/deadlines
- Support the resolution of emerging issues (e.g. new safety or quality finding) and the associated risk communications to stakeholders
- Provide regulatory guidance to internal business partner on messaging, promotional material review and PAAB responses
- Monitor the regulatory environment, interpret changes, analyze gaps and support the conduct of impact assessment, and participate in implementation into systems/processes
- Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment

**Qualifications**:
**Education**:

- A minimum of a BSc degree in Biological or related sciences is required

Experience and Skills:
Required:

- 1-3 years Regulatory Affairs pharmaceutical or related experience, which can include Regulatory Affairs certification
- Basic knowledge of the drug development process
- 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
- Ability to interpret and understand Regulations in the context of the scientific and commercial environment
- Good scientific writing skills
- Ability to interpret and summarize clinical data
- Problem solving and analytical skills
- Project management skills and ability to manage multiple priorities
- Good communication (oral and written) and strong interpersonal skills
- Negotiation and influencing skills
- Experience working within teams

Preferred:

- Experience in the oncology or immunology therapeutic area
- Experience in preparing therapeutic/labeling submissions
- Ability to interpret basic biostatistics

Other:

- Minimal travel required

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