Regulatory Affairs Specialist

Role Description

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