Regulatory Associate (Pharmaceutical submissions)

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Associate Consultant with a focus on Pharmaceutical submissions with HYBRID option in Toronto, Ontario, Canada for 12 months CONTRACT, to join one of our major pharmaceutical clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.

Responsibilities

• Regulatory submission support under the direction of Regulatory team member

o Coordination of the preparation and maintenance of regulatory submissions and filings
o Assess, prepare and compile regulatory submissions (e.g. safety labeling changes) and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products.
o Assist in the preparation and submission of larger submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs).
o 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.
o Engage with other functions and global regulatory teams to facilitate regulatory activities.
o Apply appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.

• Execute assigned regulatory activities to support compliance requirements and product labeling.

o Complete regulatory activities as assigned within required timelines to meet company and Health Canada requirements.

Personnel Qualifications:

• A minimum B.Sc. in Biological or related sciences.
• A minimum of 1 year of Regulatory Affairs pharmaceutical or related experience is required, preferably in Canada

Required Regulatory Associate Core/Technical competency requirements:

• Basic 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 and obtaining approval of therapeutic/labeling submissions
• Experience in eCTD submissions and knowledge of Health Canada eCTD regulations and requirements in specific
• Experience with managing the operational aspect of Canadian regulatory submissions (all types; NDS, SNDS, etc)
• Demonstrated project or submission management capabilities
• Demonstrated effective interpersonal, teamwork, and communication skills
• Ability to use Regulatory Information systems
• Ability to work in a matrix environment
• Good problem solving and analytical skills
• Therapeutic area and product knowledge is preferred
• Ability to exercise solid judgment and communicate effectively with varied levels of the organization required

AI Disclosure:

We are using AI as part of the recruitment process.

Vacancy:

Advertisement relates to a current vacancy.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific .            

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.

#LI-PR1 #LI-Hybrid #Contract

The base salary pay range represents the anticipated low and high range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Canada Pay Range
$35—$42 CAD