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Regulatory analyst Offres d'emploi - Kitchener, ON

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Regulatory analyst • kitchener on

Dernière mise à jour : il y a 14 heures
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Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Apotex Inc.Golden Horseshoe, ON, Canada
Canadian-based global health company that produces high-quality, affordable medicines for patients around the world.Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercia...Voir plusDernière mise à jour : il y a 28 jours
  • Offre sponsorisée
Business analyst - computer systems

Business analyst - computer systems

Business Analyst Computer SystemsOntario, Canada
CDI
Overview Languages : English Education : Bachelor's degree Experience : 1 year to less than 2 years On site Work must be completed at the physical location. There is no option to work remotely.Responsi...Voir plusDernière mise à jour : il y a plus de 30 jours
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Senior Integration Analyst

Senior Integration Analyst

Apex Systemswaterloo, on, Canada
Temps plein
Integration Functional Analyst.We are seeking a skilled and proactive Integration Functional Analyst to join our team and support the development and alignment of Electronic Medical Record (EMR) ve...Voir plusDernière mise à jour : il y a 1 jour
Manager, Regulatory Affairs (Temporary Full Time)

Manager, Regulatory Affairs (Temporary Full Time)

CB CanadaOntario, Canada
80 000,00 $CA – 100 000,00 $CA par an
Are you looking to make a difference in a patient’s life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference.A...Voir plusDernière mise à jour : il y a plus de 30 jours
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Data Analyst

Data Analyst

HCLTechOntario, Canada
90 000,00 $CA par an
Temps plein
Mandatory skills : PurView experience, Databricks, Metadata tagging, Data Governance, Data Classification & tagging.Location city(s) : Toronto or London or Winnipeg. Eligibility : Candidates with 5 - 7...Voir plusDernière mise à jour : il y a 4 jours
Manager of Environment & Regulatory Affairs

Manager of Environment & Regulatory Affairs

CSG TalentThunder Bay District, Ontario
140 000,00 $CA – 163 000,00 $CA par an
CDI
The Role : (Residential Position - Ontario).Join an ambitious Canadian based gold-focused exploration and development company, where you will lead the Environmental department on site.This company p...Voir plusDernière mise à jour : il y a plus de 30 jours
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Financial Analyst

Financial Analyst

Robert HalfCambridge, ON
32,00 $CA –38,00 $CA par heure
Temporaire
Quick Apply
We are in search of a Financial Analyst to join our team in Guelph, Ontario.This role is essential in the public sector industry, as it involves various responsibilities such as processing and reco...Voir plusDernière mise à jour : il y a 2 jours
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Cost Analyst

Cost Analyst

PWO Canada Inc.Kitchener, ON, Canada
Temps plein
PWO Canada is a Tier 1 and Tier 2 supplier for auto manufacturers globally.We are one of five subsidiaries in the PWO AG Group, manufacturing lightweight metal components for the automotive industr...Voir plusDernière mise à jour : il y a plus de 30 jours
Manager, Regulatory Affairs

Manager, Regulatory Affairs

Innomar StrategiesRemote, ON
151 600,00 $CA – 281 500,00 $CA par an
Télétravail
Temps plein
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 ...Voir plusDernière mise à jour : il y a plus de 30 jours
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Compliance & Regulatory Affairs Manager

Compliance & Regulatory Affairs Manager

Willson International Limitedkitchener, on, Canada
Temps plein
The Manager, Compliance & Regulatory Affairs will oversee the day-to-day operation of the Regulatory and Compliance department with a Brokerage company, while providing answers and support to clien...Voir plusDernière mise à jour : il y a 1 jour
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  • Nouvelle offre
Compliance Analyst

Compliance Analyst

BET99waterloo, on, Canada
Temps plein
BET99 is Canada's Premiere Online Sportsbook and Casino.Since our launch in 2020, we have consistently innovated the online gaming landscape every step of the way, exponentially growing our custome...Voir plusDernière mise à jour : il y a 14 heures
Data Analyst

Data Analyst

AurumOntario, ON, CAN
60 000,00 $CA – 65 000,00 $CA par an
Temps plein +1
Quick Apply
We are seeking a detail-oriented and motivated Data / Procurement Analyst to Join our team.This role involves supporting the procurement and supply chain functions by analyzing data, identifying tren...Voir plusDernière mise à jour : il y a 1 jour
Regulatory and Financial Audit Specialist

Regulatory and Financial Audit Specialist

DefinityWaterloo, ONT, Canada
66 300,00 $CA – 122 100,00 $CA par an
Regulatory and Financial Audit Specialist.Regulatory Compliance Management, Policy Management and Internal Controls Over Financial Reporting (ICFR) programs. The Regulatory and Financial Audit ...Voir plusDernière mise à jour : il y a plus de 30 jours
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Actuarial Analyst

Actuarial Analyst

Farm Mutual ReCambridge, ON, Canada
Temps plein
Farm Mutual Re is a mutual reinsurer that offers tailored reinsurance solutions for varied insurance lines and helps mutual insurers keep their promises by providing financial stability and insuran...Voir plusDernière mise à jour : il y a 22 jours
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Business Analyst

Business Analyst

VLink Inckitchener, on, Canada
Temps plein
Job Title : Business Analyst - Senior.Location : Toronto, Ontario, Canada.Employment Type : Long Term Contract.Started in 2006 and headquartered in Connecticut, VLink is one of the fastest growing dig...Voir plusDernière mise à jour : il y a 1 jour
Compliance Analyst

Compliance Analyst

Securian CanadaWaterloo, ON, CA
Quick Apply
Securian Canada maintains high ethical market conduct standards of our distribution channels.You will conduct desk and on-site reviews of contracted agencies and their advisors according to applica...Voir plusDernière mise à jour : il y a plus de 30 jours
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Data Analyst

Data Analyst

PeroptyxKitchener
21,85 $CA –25,30 $CA par heure
At Peroptyx, we are looking for Data Analysts who will review mapping data for digital mapping applications.Your research capabilities will validate and ensure that the navigation of certain routes...Voir plusDernière mise à jour : il y a plus de 30 jours
Regulatory Compliance Manager

Regulatory Compliance Manager

Home Hardware StoresHybrid Remote, St. Jacobs, Ontario
90,00 $CA par heure
Télétravail
We’re more than Canada’s largest independent hardware and building supplies retailer—we’re part of communities across the nation. As a Regulatory Compliance Manager, you will assist with the develop...Voir plusDernière mise à jour : il y a plus de 30 jours
  • Offre sponsorisée
Regulatory Affairs Manager (Part-Time, Canada Based)

Regulatory Affairs Manager (Part-Time, Canada Based)

Advanced Clinicalwaterloo, on, Canada
Temps partiel
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the ...Voir plusDernière mise à jour : il y a 1 jour
Sr. Lab Analyst, LC-MS / MS Operator

Sr. Lab Analyst, LC-MS / MS Operator

Pharma Medica Research Inc.Canada, Ontario, Canada, Canada
Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations.We are currently...Voir plusDernière mise à jour : il y a plus de 30 jours
Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Apotex Inc.Golden Horseshoe, ON, Canada
Il y a 28 jours
Description de poste

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

For more information visit : www.apotex.com .

Job Summary

The Associate Director, Regulatory Affairs is responsible for managing and supporting the registration and post-approval maintenance of Searchlight products in various jurisdictions. The position manages junior RA internal staff as well as third party providers / contractors and works closely with the company’s business partners to achieve company objectives.

Job Responsibilities

  • Manage and support the submission process for new drug submissions and post-approval changes in various jurisdictions in support of business objectives.
  • Develop responses to regulatory agency requests (Health Canada, EU, FDA), and / or review responses and documents intended for submission to agencies to ensure compliance with regulatory standards.
  • Plan and conduct pre-submission meetings with Health Canada.
  • Provide CMC expertise and author sections of regulatory drug submissions for new products and post-approval changes.
  • Actively manage and collaborate with external service providers.
  • Coordinate the completion of and review agreements with partners and service providers.
  • Create, maintain and identify the need for regulatory processes to ensure compliance with applicable regulatory requirements.
  • Review and approve product labelling. Coordinate revisions to labelling (where necessary).
  • Review Canadian promotional and advertising materials to ensure compliance with Health Canada and the Pharmaceutical Advertising Advisory Board (PAAB) Code of Advertising Acceptance.
  • Maintain awareness of the international regulatory environment and assess impact of pertinent changes that may affect the organization.
  • Provide regulatory expertise in support of the Searchlight product portfolio and business development opportunities.
  • Contribute to strategic planning for regulatory projects.
  • Prepare scientific briefing packages and identify possible issues / risks in product registrations and develop strategies for resolution.
  • Conduct diligence reviews and generate reports to support company objectives in acquiring new products.
  • Responsible for assessing new regulatory or updated regulatory requirements and identifying impact to the organization.
  • Responsible for identifying and supporting process improvements in regulatory practices.
  • Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
  • Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
  • Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
  • Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
  • Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
  • All other duties as assigned.

Job Requirements

Education

  • University degree in a science-related discipline.
  • Post-Graduate Certificate in Pharmaceutical Regulatory Affairs.
  • Comprehensive knowledge and experience in the Canadian regulatory environment and Health Canada regulations, policies and guidelines.
  • Knowledge, Skills and Abilities

  • Ability to work in a cross-functional environment.
  • Good organizational, problem solving and analytical skills.
  • Excellent written and oral communication skills.
  • Strong attention to detail.
  • Sound technical knowledge of chemistry and manufacturing principles.
  • Strong leadership skills and ability to lead, coach, mentor and develop junior staff.
  • Ability to handle multiple projects and priorities, while meeting project deadlines.
  • Knowledge of Canadian Drug and Device Legislation.
  • Knowledge of global drug legislation and experience with ex-Canada submissions is an asset.
  • Self-motivated and able to work with minimal supervision, as well as part of a team.
  • Computer literacy with proficiency in Microsoft Word, Excel, PowerPoint, Adobe.
  • Experience

  • 8 to 10 years in Regulatory Affairs or related relevant experience.
  • Proven success in securing regulatory authorizations for new products and post-approval changes.
  • Experience in pharmacovigilance.
  • Experience with document management and CTD / e-CTD.
  • Experience managing and developing junior staff.
  • At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

    Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

    Seniority level

    Mid-Senior level

    Employment type

    Full-time

    Job function

    Science

    Industries

    Pharmaceutical Manufacturing

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