Senior Regulatory Affairs Associate

When our values align, there's no limit to what we can achieve.

At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients.

We are seeking a Senior Regulatory Affairs Associate to join our team. As a Senior Regulatory Affairs Associate , you’ll be joining a fast-paced, driven environment that’s helping to make life-changing difference to patients by compiling Health Canada CTA submissions for various clients, completing HC 3011 Application Forms, and reviewing labels.

Through the collaboration, and diversity, of teams as a Senior Regulatory Affairs Associate you will be provided with multiple opportunities to excel and discover where your skills can take you.

If you have extensive experience with clinical trial submissions for Health Canada, enjoy client interaction, and love working from home, we’d love to connect!

A Senior Regulatory Affairs Associate will have :

Experience with Canadian Regulatory Authority, Health Canada (HC)Experience with eCTD and electronic CTA submission to the following Health Canada departments : Pharmaceutical Drugs Directorate (PDD) (previously known as the Therapeutic Products Directorate (TPD)), the Biological and Radiopharmaceutical Drugs Directorate (BRDD) (previously known as the Therapeutic Products Directorate (BGTP)), and the Natural and Non-prescription Health Products Directorate (NNHPD)

Extensive knowledge of Division 5 Regulations

Experience compiling documents from Module 1-3 of the Canadian Clinical trial dossier to include experience with the Quality of Summary form, IMPD, Clinical trial site information, Labels, etc.

Experience reviewing labels in English (past label review experience in French is a plus)

Experience completing the HC 3011 Application Form

Previous experience requesting and / or participating in Pre-submission meetings

Experience with initial submissions, maintenance, and closure (iCTA, CTA-A, CTA-N)

A Senior Regulatory Affairs Associate will be responsible for :

Project Execution

Works effectively within a team environment but may work independently delivering services within their area of competence.

Works within broad project guidelines as directed by the project lead and / or technical SMEs.

Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager.

Capitalizes on opportunities to improve one’s own performance and seeks feedback from the project lead and colleagues.

Applies information provided by the project lead or senior colleagues to complete assigned project activities.

Produces quality work that meets the expectations of project lead and the client.

May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects when serving as a Project Lead

Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.

g. project set-up, forecasting and financial entries, invoicing, etc.)

Functions as the main client contact and ensures accurate project reporting is in place.

Ensures that the project team delivers to meet the client expectations for quality and timeliness.

Ensures that appropriate risk identification and issue-escalation procedures are in place.

Ensures project specific training compliance of the project team.

Ensures and / or manages project financials including provision of accurate revenue forecasts.

Ensures that the project team understand and work to the scope of the contract.

Identifies new opportunities through Change in Scope or add-on business from existing work.

Ensures timely project close-out activities are completed.

Consulting Activities and Relationship Management

Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and / or Technical SME

Delivers consulting services within personal area of expertise under the guidance of the project lead and / or Technical SME

Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the Project Lead and / or Technical SME

Identifies project and internal issues to senior colleagues and Project Lead and / or technical SME and provides proposed solutions.

Interacts professionally at all working levels within a client organization and within Parexel.

Identifies project and / or client needs to the Project Lead and or Technical SME and collaborates with senior staff to define a proposed solution.

Interactions result in clients expressing satisfaction with service provided.

May assist in preparing and / or delivering a presentation with the support of senior colleagues.

Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope ·Identifies and alerts Parexel Regulatory management to opportunities for follow-on business or necessary changes in project scope.

Business Development

Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience

Communicates potential new business leads to Parexel Regulatory management and account managers

May participate in project scoping calls and / or proposal preparation

with the support of senior colleagues

Other Parexel Related Activities

Meets established metrics as specified in scorecard on an annual basis

Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives / projects or as a mentor as requested by management

Defines self-development activities to keep current within the industry (i.e. maintain membership in a relevant industry and / or scientific / technical association)

Skills

Project management knowledge

Client-focused approach to work

Results orientation

Teamwork and collaboration skills

Consulting skills

Excellent interpersonal and intercultural communication skills, both written and verbal

Critical thinking and problem-solving skills

Language

Proficiency and extensive working knowledge in English. French language skills are a plus.

Knowledge and Experience

2-3 years of experience submitting clinical trials in Canada

Education

Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline