Top Benefits
About the role
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
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Toronto, Ontario, Canada
Job Description:
We are searching for the best talent for our Regulatory Affairs Associate position, located in Toronto, Ontario, Canada, under the flexible working model (at least 3 days in office).
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Purpose: The Regulatory Affairs Associate will support the regulatory activities to obtain and maintain product registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures. The Associate as a member of a team will help develop and implement regulatory strategies to meet project deliverables. As a subject matter authority for Regulatory Affairs the individual will provide guidance to local and global business partners.
You will be responsible to:
- 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 partners 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 collaborators
- Provide regulatory guidance to internal business partners 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:
Required:
- A minimum of a BSc degree in Biological or related sciences is 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
- 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
- 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 <5%
#LI-Hybrid
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, we’re empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.
All of this is possible because of our people. We’re passionate innovators who put people first, and through our purpose-driven culture and talented workforce, we are stronger than ever.
Learn more at https://www.jnj.com. Community Guidelines: http://www.jnj.com/social-media-community-guidelines
Top Benefits
About the role
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
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Toronto, Ontario, Canada
Job Description:
We are searching for the best talent for our Regulatory Affairs Associate position, located in Toronto, Ontario, Canada, under the flexible working model (at least 3 days in office).
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Purpose: The Regulatory Affairs Associate will support the regulatory activities to obtain and maintain product registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures. The Associate as a member of a team will help develop and implement regulatory strategies to meet project deliverables. As a subject matter authority for Regulatory Affairs the individual will provide guidance to local and global business partners.
You will be responsible to:
- 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 partners 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 collaborators
- Provide regulatory guidance to internal business partners 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:
Required:
- A minimum of a BSc degree in Biological or related sciences is 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
- 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
- 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 <5%
#LI-Hybrid
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, we’re empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.
All of this is possible because of our people. We’re passionate innovators who put people first, and through our purpose-driven culture and talented workforce, we are stronger than ever.
Learn more at https://www.jnj.com. Community Guidelines: http://www.jnj.com/social-media-community-guidelines