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Regulatory affairs • hamilton on

Dernière mise à jour : il y a 20 heures
  • Offre sponsorisée
Regulatory Affairs Associate

Regulatory Affairs Associate

Nora Pharmaontario, Canada
Temps plein +1
Regulatory Affairs Associate - Permanent Full Time (Remote).Nora Pharma is a Canadian pharmaceutical company specializing in the distribution of generic drugs across the country.The company offers ...Voir plusDernière mise à jour : il y a 7 jours
  • Offre sponsorisée
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 27 jours
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
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
  • Offre sponsorisée
Corporate Secretarial Advisor

Corporate Secretarial Advisor

Desjardins GroupON, Canada
Corporate Secretarial Advisor page is loaded.Apply remote type The work arrangement for the position is hybrid work locations Ontario time type Full time posted on Posted Yesterday job requisition ...Voir plusDernière mise à jour : il y a 14 jours
Associate / Director of Regulatory Affairs (remote US or Canada)

Associate / Director of Regulatory Affairs (remote US or Canada)

ParexelRemote, Ontario, Canada
Télétravail
When our values align, there's no limit to what we can achieve.Exciting opportunity to join Parexel as an Associate / Director of Regulatory Affairs!. As an Associate / Director of Regulatory Affairs, y...Voir plusDernière mise à jour : il y a 28 jours
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Vice President, Medical & Academic Affairs

Vice President, Medical & Academic Affairs

North York General HospitalGolden Horseshoe, ON, Canada
Temps plein
The Director, PI Portfolio Management will play a fundamental role within the Personal Insurance Portfolio Management team to ensure that Economical, as a public company, will reach its Personal In...Voir plusDernière mise à jour : il y a 1 jour
Associate Director of Student Affairs (52638)

Associate Director of Student Affairs (52638)

International Education CorporationOntario, CA
62 400,00 $CA – 80 000,00 $CA par an
Working at our employee-owned company is more than just a great career - its an investment in yourself.Our mission is to drive personal and community transformation by empowering students to make a...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
  • Offre sponsorisée
Medical Affairs Director, Orthopaedics

Medical Affairs Director, Orthopaedics

Johnson & JohnsonON, Canada
Temps plein
Job Description - Medical Affairs Director, Orthopaedics (2506237303W).Johnson & Johnson MedTech Canada is committed to advancing the global healthcare landscape through innovative solutions in the...Voir plusDernière mise à jour : il y a 8 jours
Associate Validation Engineer

Associate Validation Engineer

Sotera HealthON, Canada
130 000,00 $CA – 160 000,00 $CA par an
Temps plein
Reporting to the Quality Assurance (QA) Manager or equivalent manager / supervisor, Associate Validation Engineer will provide management with information and data on all key aspects of each customer...Voir plusDernière mise à jour : il y a plus de 30 jours
Senior Medical Manager, Liver Diseases

Senior Medical Manager, Liver Diseases

Gilead Sciences Canada, Inc.Ontario East, Ontario, Canada
76 499,00 $CA – 95 628,00 $CA par an
Temps plein
Lead the development, execution and coordination of the Medical Affairs plan of action (POA) for Liver Diseases.Co-lead the launch and pre-launch activities for new therapies in Gilead Canada's liv...Voir plusDernière mise à jour : il y a plus de 30 jours
regulatory compliance specialist

regulatory compliance specialist

Queen's Elite Academy of CanadaHamilton, ON, CA
49,00 $CA par heure
Temps plein +1
Analyze and provide advice on the managerial methods and organization of an establishment.Develop quality management and quality assurance standards. Conduct research to determine efficiency and eff...Voir plusDernière mise à jour : il y a plus de 30 jours
Director, Communications And Public Affairs

Director, Communications And Public Affairs

Meridia Recruitment SolutionsOntario
39 040,00 $CA – 43 200,00 $CA par an
Director, Communications and Public Affair.Meridia Recruitment Solutions has partnered up with Restaurants Canada (RC) on their search for a Director, Communications & Public Affairs to join their ...Voir plusDernière mise à jour : il y a plus de 30 jours
Telesat Director, Government and Public Affairs

Telesat Director, Government and Public Affairs

BoydenON, CA
Telesat is a leading global provider of satellite solutions.They are developing Telesat Lightspeed, the world’s most advanced Low Earth Orbit satellite network that will connect everyone, everywher...Voir plusDernière mise à jour : il y a plus de 30 jours
Manager Scientific and Regulatory Affairs Compliance and Innovation

Manager Scientific and Regulatory Affairs Compliance and Innovation

Coca ColaOntario,ON,Canada
108 000,00 $CA – 126 000,00 $CA par an
Temps plein
Candidates must be currently located in Toronto, Ontario, Canada area.Relocation is not provided for this role.Candidates must be currently located in the Atlanta, Georgia, or Chicago, Illinois are...Voir plusDernière mise à jour : il y a plus de 30 jours
  • Offre sponsorisée
Documentation Specialist

Documentation Specialist

Brunelontario, Canada
Temps plein
Regulatory Affairs Documentation Specialist (renewable contract).We are currently hiring a Documentation Specialist – Regulatory Affairs for our client based in Toronto. The Documentation Specialist...Voir plusDernière mise à jour : il y a 10 jours
  • Offre sponsorisée
Associate Counsel, Original Series - Canada

Associate Counsel, Original Series - Canada

NetflixON, Canada
Temps plein
Netflix is one of the world's leading entertainment services, with 283 million paid memberships in over 190 countries enjoying TV series, films, and games across a wide variety of genres and langua...Voir plusDernière mise à jour : il y a 1 jour
  • Offre sponsorisée
  • Nouvelle offre
Chief of Staff / Executive-Vice President, Medical Affairs, Niagara Health

Chief of Staff / Executive-Vice President, Medical Affairs, Niagara Health

Odgers BerndtsonGolden Horseshoe, ON, Canada
100 000,00 $CA – 125 000,00 $CA par an
Temps plein
Chief of Staff / Executive-Vice President, Medical Affairs, Niagara Health.Personal and Home Support Workers play a pivotal role in our health care system. At Spectrum Health Care, they work closely...Voir plusDernière mise à jour : il y a 20 heures
Regulatory Affairs Associate

Regulatory Affairs Associate

Nora Pharmaontario, Canada
Il y a 7 jours
Type de contrat
  • Temps plein
  • CDI
Description de poste

Regulatory Affairs Associate - Permanent Full Time (Remote)

Nora Pharma is a Canadian pharmaceutical company specializing in the distribution of generic drugs across the country. The company offers a range of generic products and related services to ensure customer satisfaction.

Position Overview :

We are seeking a motivated and experienced Regulatory Affairs Associate to join our regulatory team and support regulatory activities related to Health Canada. This is an excellent opportunity for someone looking to advance their career in regulatory affairs within a dynamic and growing organization.

Responsibilities :

  • Support the preparation, compilation, and submission of regulatory filings for different dosage forms to Health Canada (NDS, S / NDS, ANDS, S / ANDS etc.).
  • Maintain regulatory documents and submissions in compliance with company procedures and Health Canada regulations, ensuring accuracy, completeness, and timeliness.
  • Review various submission-related documents, including Batch records, Process validation Reports, Stability protocols and reports, Specifications and Testing procedures, Analytical Validation Reports, Pharmaceutical development reports, ensuring accuracy and completeness.
  • Communicate with internal and external stakeholders obtain documents required to support regulatory submissions, communicate the company’s position and work to eliminate hurdles.
  • Assist in the preparation of responses to regulatory queries and requests for additional information from the relevant stakeholders.
  • Review labeling, packaging, and promotional materials for regulatory compliance.
  • Track and report on the status of regulatory submissions and approvals to stakeholders.
  • Support regulatory audits and inspections by health authorities, ensuring all documentation is accurate and readily available.
  • Stay informed about changes in Canadian regulations and guidance documents relevant to pharmaceuticals / biosimilars.
  • Monitor and maintain regulatory compliance of the product through post-approval activities and filings.
  • Utilize eCTD software to prepare, manage, and submit electronic regulatory submissions to Health Canada. Ensure eCTD submission standards and requirements are met for successful filings.
  • Maintain regulatory status tracker / files / database.
  • Additional duties as assigned by the Regulatory head.

Skills & Qualifications :

  • Bachelor's degree in life sciences, pharmacy, chemistry or related Health Sciences, advanced degree (e.g., MSc) preferred.
  • Graduate Certificate in Pharmaceutical Regulatory Affairs.
  • Must have a minimum of 2 to 3 years of experience filing regulatory submissions with Health Canada.
  • Knowledge of CMC requirements and able to analyze and draw conclusion from scientific data.
  • Experience with eCTD software.
  • Strong interpersonal skills and ability to foster strong independent working relationships with key stakeholders (internally and externally).
  • Knowledge of Canadian Food and Drugs Act and Food and Drug Regulations, GMPs, ICH Guidelines and Health Canada Policies & Guidelines.
  • Ability to prioritize workload and effectively manage multiple projects in a fast-paced, results oriented environment to ensure all deadlines are met.
  • Excellent organization, written and oral communication skills.
  • Strong commitment to quality, accuracy and detail.
  • Ability to work well under pressure in a team-based environment.
  • Strong problem-solving skills and a proactive approach to tasks.
  • Benefits :

    Insurance after 3 months

    Language Requirement :

  • English
  • French if known, is an asset.
  • Schedule :

    Monday to Friday 9 am to 5 pm EST.

    Location : Canada, remote. Must be able to work Eastern Hours.