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Regulatory specialist Jobs in Quebec City, QC

Last updated: 18 hours ago
  • Promoted
Sr Regulatory Consultant

Sr Regulatory Consultant

Syneos HealthQuebec City, QC, Canada
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into...Show moreLast updated: 17 days ago
Regulatory Risk Management Advisor

Regulatory Risk Management Advisor

IA Financial GroupQuébec, Quebec
Permanent
Show moreLast updated: 5 days ago
  • Promoted
Sales Specialist

Sales Specialist

RONAlévis, QC, Canada
Full-time
At RONA, our employees let their passion blossom every day.Our teams are driven by the desire to help people bring their projects to life and are committed to making a difference in the communities...Show moreLast updated: 1 day ago
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Sales Specialist

Sales Specialist

RONA inc.Lévis, Quebec, Canada
At RONA, our employees let their passion blossom every day.Our teams are driven by the desire to help people bring their projects to life and are committed to making a difference in the communities...Show moreLast updated: 15 days ago
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Field Sales Specialist

Field Sales Specialist

YESAQuebec, Canada, Canada
CA$80,000.00 yearly
Full-time
Bilingual Field Sales SpecialistJob Type : Full-time (Monday to Friday)Location : Quebec Province (on-the-road)Base Salary : $39,000 annuallyCommission : Up to $80,000 annually (on top of base salar...Show moreLast updated: 5 days ago
Claims Quality Specialist, Governance (Quebec-bilingual)

Claims Quality Specialist, Governance (Quebec-bilingual)

DefinityMontreal, QUE, Canada
CA$66,300.00–CA$122,100.00 yearly
The Specialist, National Claims Quality Assurance will lead the implementation and execution of a technical file review program within the claims area of the business including coverage of multiple...Show moreLast updated: 30+ days ago
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IT Specialist

IT Specialist

Dispomed ltéeLanaudière-Nord (Saint-Esprit), QC, Canada
Full-time
Who are we?Dispomed is a Quebec-based company founded in 1982, headquartered in Joliette (QC), that manufactures and sells high-quality veterinary equipment worldwide. Dispomed is a dynamic, family-...Show moreLast updated: 1 day ago
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Change Management Specialist

Change Management Specialist

MytechtalQuebec City, Quebec, Canada
We are seeking an experienced and dynamic Organizational Change Management.OCM) Lead for one of our clients to join to their IT organization. The OCM lead requires a deep and broad knowledge of chan...Show moreLast updated: 30+ days ago
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  • New!
Residential Financial Specialist

Residential Financial Specialist

National BankFassett, CA
Full-time
A career as Residential Financial specialist is about being part of the transformation and having a direct impact on the customer. As a Residential Financial Specialist, you act as an expert for bra...Show moreLast updated: 22 hours ago
Head of Department - Regulatory Department

Head of Department - Regulatory Department

OcéanQuébec, CA
CA$48,000.00–CA$55,000.00 yearly
ARE YOU LOOKING TO JOIN A GREAT COMPANY WHERE YOUR CONTRIBUTION WILL BE RECOGNIZED?.READ ON, THIS OFFER IS PERFECT FOR YOU!. We are actively seeking a Head of Department – Regulatory Department who ...Show moreLast updated: 30+ days ago
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Documentation Specialist

Documentation Specialist

SwoonQuebec, Canada
CA$24.75 hourly
Full-time
Documentation Specialist (Bilingual - French & English).Overview : Our client is seeking a detail-oriented and customer-focused. TPS (Corporate Card Implementation).This role requires working with va...Show moreLast updated: 16 days ago
  • Promoted
Marketing Specialist

Marketing Specialist

Lavanett Equipment Inc.Greater Montreal Metropolitan Area, Canada
Lavanett is a leading provider of commercial laundry equipment and supplies.We are dedicated to offering top-quality products and exceptional service to our clients. As we look to expand our reach i...Show moreLast updated: 16 days ago
Manager, Regulatory Compliance - Gas

Manager, Regulatory Compliance - Gas

Liberty UtilitiesSt-Damase, Quebec,
CA$95,000.00 yearly
This position may be located at any Liberty location •.This position is the owner of gas compliance maintenance plan standards and reporting, and is responsible for monitoring adherence to standards...Show moreLast updated: 30+ days ago
  • New!
Email Marketing Specialist

Email Marketing Specialist

NorthScaleQuébec City, Quebec, Canada
Remote
Part-time
Quick Apply
Our mission is to elevate companies to the top of their industries and secure their position as leaders by leveraging cutting-edge marketing strategies and innovative technology.We craft unique, ta...Show moreLast updated: 19 hours ago
Manager, Regulatory Affairs

Manager, Regulatory Affairs

Innomar StrategiesRemote, Quebec
CA$151,600.00–CA$281,500.00 yearly
Remote
Full-time
Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...Show moreLast updated: 30+ days ago
  • Promoted
Field Application Specialist

Field Application Specialist

COPAN Diagnostics, Inc.Quebec City metropolitan community, QC, Canada
Full-time
The Field Application Specialist.The Field Application Specialist is responsible for high-level technical and application training to Copan’s customers. The primary focus of this position is to assi...Show moreLast updated: 16 days ago
  • Promoted
Logistic Account Specialist -

Logistic Account Specialist -

FuelGreater Montreal Metropolitan Area, Canada
Il y a cet instant où tout semble se mettre en place.Cet instant où le défi le plus complexe se transforme en solution créative, où le problème devient soudainement une opportunité.Ces instants son...Show moreLast updated: 29 days ago
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International Logistics Specialist

International Logistics Specialist

THE GTI GROUPGreater Montreal Metropolitan Area, Canada
Full-time
JOB DESCRIPTION – International Logistics Specialist (Project Cargo).The GTI Group is currently seeking an experienced International Logistics Specialist to join our growing Montreal team.The ideal...Show moreLast updated: 11 days ago
Regional Manager - Montreal Centre, Quebec City and South Shore

Regional Manager - Montreal Centre, Quebec City and South Shore

EightSix NetworkQC
CA$80,000.00–CA$90,000.00 yearly
Requisition ID : Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.Leading a team of Investment Specialists for an assigned market area, the Regio...Show moreLast updated: 30+ days ago
  • Promoted
  • New!
Sales Specialist, Appliances

Sales Specialist, Appliances

RONA+Sainte-Marthe, CA
Full-time
At RONA, our employees let their passion blossom every day.Our teams are driven by the desire to help people bring their projects to life and are committed to making a difference in the communities...Show moreLast updated: 18 hours ago
Sr Regulatory Consultant

Sr Regulatory Consultant

Syneos HealthQuebec City, QC, Canada
17 days ago
Job description

Description

Senior Regulatory Consultant

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities

  • Responsible for day-to-day contribution to project teams and projects.
  • Acts as a representative of the GRAS regulatory department with other departments.
  • Contributes technical expertise to proposals and assists with Business Development initiatives.
  • Understands project budgets, scope of projects, allocated hours, and tracks compliance.
  • Interacts with internal and external personnel, clients, and technical experts on projects.
  • Conducts regulatory research on projects as needed.
  • Provides operational advice to clients.
  • Prepares consulting reports under guidance.
  • Arranges, leads, and reports on client meetings.
  • Contributes to regulatory agency meetings.
  • Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.
  • Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.
  • Acts as a resource for technical knowledge.
  • Participates in quality improvement efforts to increase overall operational efficiency.
  • Contributes to the building of the regulatory systems and infrastructure needed for GRAS.
  • Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.
  • Provides internal training in appropriate areas of expertise to other Departments.
  • May act as a Line Manager to a small team, dependent on the location.
  • Qualifications

    What we’re looking for

  • BS degree, preferably in a science-related field or equivalent experience in science / regulatory / medical writing-related field. PhD preferred.
  • Experience with preparation and approval of regulatory submissions to Health Canada
  • Moderate regulatory, pharmaceutical / medical device related experience.
  • Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP / PMP an advantage.
  • Excellent interpersonal / communication skills including excellent written and verbal communication skills.
  • Excellent customer service skills, with the ability to work both as a team member and independently.
  • Good quality management skills.
  • Problem-solving and decision-making skills.
  • Advanced skills in Microsoft Office Applications.
  • Ability to interact with staff from multiple departments and offices to establish project standards.
  • Good initiative, adaptability, and pro-activity.
  • Strong analytical skills, good attention to detail.
  • Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
  • Fluent in speaking, writing, and reading English.
  • Get to know Syneos Health

    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

    No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    Additional Information :

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.