Regulatory Affairs Consultant (Bilingual French and English)

If you are fluent in French and English and have extensive experience with clinical trial submissions for Health Canada, enjoy client interaction, and love working from home, we’d love to connect regarding a home-based Regulatory Affairs Consultant that is currently available on Parexel’s Regulatory Affairs Team!

A Regulatory Affairs Consultant will have:

•             Experience with Canadian Regulatory Authority, Health Canada (HC)

•             Experience with ECs/REB/IRBs

•             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)

Additional support as needed

Providing strategic advice regarding Canadian regulatory requirements to an internal or external stakeholder.

A Regulatory Affairs Consultant will also be responsible for:

Project Execution

·Typically works within a team environment but may work independently delivering services within their technical area of expertise

·Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts

·Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes

·Capitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project technical lead

·Seeks out information from previous projects, other client work or from colleagues to complete assigned project activities

·Produces quality work that meets the expectations of project Team 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

Consulting Activities and Relationship Management

·Follows and implements the organization’s consulting models and methodologies

·Provides technical and/or business consulting services within personal area of expertise

·Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability

·Collaborates with colleagues and client to identify and resolve technical and process issues

·Leverages senior colleagues to discuss and propose resolutions to

possible problems or conflicts. Seeks guidance periodically on appropriate methods of executing project activities

·Interacts professionally at multiple levels within a client organization and within Parexel

·Proactively assesses client needs and develops processes and solutions to address issues

·Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided

·Interactions result in clients expressing satisfaction with service provided

·May prepare and/ or deliver presentation with the support of senior colleagues

·May deliver training

·Mentor of junior staff

·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 in order 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 and French

Knowledge and Experience

·3-4 years of experience submitting clinical trials in Canada

Education

·Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

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