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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Toronto, Ontario, Canada

Job Description:

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

We are searching for the best talent for a Senior Associate, Regulatory Affairs located in Toronto, Ontario

This Senior Associate, Regulatory Affairs is responsible for supporting 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 authority for Regulatory Affairs, the individual will provide guidance to local and global business partners.

Responsibilities

• Develop and implement regulatory strategic plans for product registration and lifecycle management, with accountability across clinical and CMC regulatory activities
• Contribute to the preparation, coordination and maintenance of regulatory submissions to Health Canada including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports, in collaboration with global and regional regulatory teams
• Manage the development, compilation, review and quality control of clinical and CMC sections of regulatory responses to Health Canada queries (e.g. Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner and in compliance with applicable regulations.
• Lead in partnership with Director, Regulatory Affairs interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling
• Support regulatory assessment of CMC changes, assist in the preparation and review of CMC documentation, including Module 3 components for eCTD submissions
• Serve as the primary Regulatory Affairs point of contact for Drug Establishment Licensing (DEL) activities in close collaboration with Product Quality.
• Maintain oversight of licensed activities and buildings, track and assess the regulatory impact of manufacturing, testing, packaging or labeling changes on establishment license.
• Contribute to process improvement initiatives aimed at increasing efficiency, consistency, and compliance across Regulatory Affairs and Product Quality interfaces.
• Work 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.
• Address key emerging issues (e.g. new safety or quality finding) and the associated risk communications.
• Provide regulatory guidance 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.
• Participate in the improvement of departmental processes and initiatives to enhance the internal work environment.

Requirements

• A minimum B.Sc. in Biological or related sciences. MSc/PhD preferred.
• Minimum 4 years (with B.Sc.) or 2 years (with MSc/PhD) of pharmaceutical or medical device Regulatory Affairs or related experience is required, holding a Regulatory Affairs and Quality Operations certification is preferred.
• 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 preparing therapeutic/labeling and Chemistry and Manufacturing submissions is desirable.
• Experience in quality assurance is an asset.
• 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.
• Ability to interpret basic biostatistics and observational research methodologies is highly desirable.
• Strong problem solving and analytical skills.
• This position is located in Toronto, Ontario and will require up to 10%

As guided by Our Credo (https://www.jnj.com/our-credo) Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Thank you for your interest in J&J. As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. If you require any accommodation at any point in the recruitment process, please let us know and we will work with you in an effort to ensure that you are able to fully participate in the process.

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

 

 

The anticipated base pay range for this position is :

107,550.00 - 157,550.00

Additional Description for Pay Transparency:

•As applicable for the role - Under current guidelines, this position is eligible for a discretionary performance bonus. •The Company uses Artificial Intelligence in its assessment of applicants. •This job posting is for an existing position.