Senior Regulatory Affairs Associate
Canada, Remote Additional Locations: Remote - Canada Job ID R0000021780 Category Regulatory / Consulting Date Posted 04/10/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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
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