Regulatory Affairs Associate

Roche

Jan 21

Applications are closed

Job
Full-time
Mid & Senior Level
Healthcare
Mississauga

Requirements

You hold a Bachelor’s Degree in a science-related field
You possess a minimum of 3-5 years work experience in Regulatory Affairs
You have experience in the pharmaceutical/biotech industry in Regulatory Affairs or Quality Department
You have in-depth knowledge of Health Canada regulations and guidelines. Additionally, knowledge of the EU and FDA regulations and guidelines are an asset, to understand where the Canadian regulations align or contrast
You have the necessary knowledge of Microsoft Office and Google Suite
You have a Pharmacy degree, or hold a Master's degree or Graduate certificate in Regulatory Affairs
You demonstrate strong communication and problem-solving skills
You have experience in process management, planning and strong ability to meet tight deadlines
You demonstrate the ability to collaborate and work as a team
You demonstrate an enterprise mindset and the ability to work effectively across cross-functional areas in a fast-paced environment

Responsibilities

You are accountable for planning, strategizing, preparing, and managing timely approvals as necessary for safety-related submissions, such as safety label updates in line with CDS, DHCPs/DILs, Risk Management Plan preparation and maintenance, PBRER submissions, and reporting of foreign actions.
You are accountable for planning, strategizing, preparing, and managing timely approvals as necessary for chemistry and manufacturing (CMC) submissions impacting the Certified Product Information Document (CPID), QOS, and Module 3, lead Yearly Biologics Product Report (YBPR) preparation and filing, and conduct environmental monitoring.
You lead or support preparation and execution of pre-submission meetings with Health Canada as necessary.
You review artwork for product packaging including inner and outer labels, and the package insert for compliance with Canadian requirements.
You support promotional material reviews.
You maintain up-to-date knowledge of, and work within, internal regulatory systems and platforms used for compliance tracking to efficiently execute day-to-day activities and support cross-functional processes.
You actively engage with the Regulatory Affairs Associate team and the Regulatory Affairs chapter, and are comfortable speaking up, and challenging when necessary.
You work collaboratively, sharing expertise within the Regulatory Affairs chapter, and across the organization, to eliminate silos and duplication, ensuring efficient use of skills.
You lead and manage implementation of improvements to regulatory processes for more efficient and successful regulatory submissions.

FAQs

What qualifications are required for the Regulatory Affairs Associate position?

A Bachelor's Degree in a science-related field is required, along with 3-5 years of work experience in Regulatory Affairs.

Is experience in the pharmaceutical or biotech industry necessary for this role?

Yes, experience in the pharmaceutical/biotech industry in Regulatory Affairs or Quality Department is required.

What specific knowledge is needed for this position?

In-depth knowledge of Health Canada regulations and guidelines is necessary, and knowledge of EU and FDA regulations is considered an asset.

What technical skills are needed for this role?

Proficiency in Microsoft Office and Google Suite is required.

Is there a preference for additional educational qualifications?

Yes, a Pharmacy degree or a Master's degree or Graduate certificate in Regulatory Affairs is preferred.

What type of skills are emphasized for this position?

Strong communication and problem-solving skills, along with the ability to collaborate and work as a team, are emphasized.

Are relocation benefits available for this role?

No, relocation benefits are not available for this position.

Where is Roche Pharma Canada's office located?

The office is located in Mississauga, Ontario.

What is Roche's stance on diversity and inclusion?

Roche fosters diversity, equity, and inclusion, believing that it is key to understanding people’s varied healthcare needs.

What kind of projects will the Regulatory Affairs Associate be involved in?

The Associate will lead special projects aimed at enhancing processes, driving change management, and participating in regulatory consultations and modernization initiatives.

Roche

Doing now what patients need next.

Science & Healthcare

Industry

10,001+

Employees

1896

Founded Year

Mission & Purpose

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).