Regulatory Affairs Specialist

Application deadline:  
Location: Toronto M2H 3S8, , Canada 
Contract type: Permanent 
Job ID: 2094 

Overall Objective: 

• Contribute to, and/or manage, the preparation and regulatory review of filings to Health Canada for both new and existing drug products. This includes the preparation of New Drug Submissions, Supplemental New Dug Submissions, Notifiable Changes, Annual Drug Notifications, and Clinical Trial Applications.

• Interpret Health Canada guidance and ensure that regulatory filings are complete with the necessary information and supporting data to support approval.

• Coordination and execution of day-to-day Regulatory Affairs processes and deliverables.

Role & Responsibilities: 

Product and Submission Related Activities:

• Responsible for the maintenance and regulatory compliance for marketed products through the filing and/or approval of post-approval change submissions.

• Responsible for the filing and approval of Clinical Trial Applications (CTAs), and related submissions.

• Assists and/or prepares submission components for New Drug Submissions (NDS) as directed.

• Assesses submission documentation and provides input into submission plans to ensure Health Canada content requirements are satisfied.

• Coordinates and manages Health Canada information requests, in collaboration with global regulatory, to ensure responses are complete and submitted within specified timelines.

• Manages the preparation and approval of mock-up labels and final artwork (including translations).

• Under general supervision, interacts with Health Canada for routine matters.

Internal Processes and Procedures:

• Ensures internal procedures, instructions, and manuals are revised accordingly with respect to the implementation of new/updated Health Canada requirements or global regulatory processes.

• Ensures the efficient and accurate maintenance for essential regulatory documents and data within LEO systems.

• Contributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvement.

• As applicable, participates in process improvement initiatives (locally and globally), and develops and implements strategies and solutions to optimize regulatory performance.

• Completes review activities for promotional and non-promotional  materials, as per local requirements.

Regulatory Intelligence:

• Participates as an active member on multi-disciplinary/cross-functional teams and provides advice on regulatory matters.

• Monitors and assesses new and revised regulatory legislation and guidelines relevant to the roles and responsibilities of the position. 

General:

• Ensure compliance with appropriate SOPs, policies and guidelines.

• Completes mandatory training within assigned timelines upon hire as well as when new policies, SOPs and guidance documents are issued.

• Participates in personal development and training sessions as required for the position.

• Strives to consistently uphold LEO Pharma’s core values.

Requirements: 

• University Bachelor of Science degree.

• Regulatory Affairs Post-Graduate Certificate (preferred but not required).

• 3+ years experience in Regulatory Affairs in the pharmaceutical industry.

• Strong understanding of Health Canada guidances/policies.

• Ability to understand and communicate scientific information.

• Excellent analytical skills with high-level attention to detail and commitment to accuracy and depth.

• Ability to work independently and in a collaborative team environment.

• Ability to effectively manage multiple deliverables in fast-paced environment.

• Strong interpersonal skills with the ability to develop and foster strong customer/peer relationships.

• Excellent communications skills (verbal, written, listening, conveying messages) with strategizing and negotiating strengths, and the ability to communicate information in a succinct and logical manner.

• Solid decision-making skills with strategic mindset. 

• Self-motivated with a high degree of initiative and sense of urgency.

• Logical thinker with the ability to anticipate, prevent potential issues, and problem solve.

• Action-oriented with the ability to identify and drive process efficiencies.

• Strong organizational skills.

• Ability to interact with professionalism and credibility.

• Accountable and dedicated to meeting high quality standards.

Behavioural Competencies:

• Accountable

• Plans and aligns

• Drives Results

• Manages complexity

• Strategic mindset

• Decision Quality

• Interpersonal savvy

• Situational adaptability

• Communicates Effectively

• Collaborates

• Builds Networks

• Customer Focus

Let's pioneer together

At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. Furthermore, LEO Pharma is a leader in thrombosis with a specific focus on cancer associated thrombosis. Leveraging our experience within venous thromboembolic diseases, we continue to engage the medical community and provide support with scientific education and training within this special area of care. At LEO Pharma, we put patients first in everything we do, and this is what makes us different! For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.  

At LEO Pharma, we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.

For certain positions, LEO Pharma might complete a background check conducted by a third party.