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Medical affairs • bradford west gwillimbury on

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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 29 jours
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Medical Interpreter

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Manager, Regulatory Affairs (Temporary Full Time)

Manager, Regulatory Affairs (Temporary Full Time)

CB CanadaOntario, Canada
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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

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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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Medical Director - Contract

Medical Director - Contract

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Hastings Manor – 476 Dundas St.West – Belleville ON – K8N 5B2 PH : 613-968-6467.Hastings Manor, Long-Term Care Facility.Hastings Manor is a 253 bed, long-term care facility located in Belleville, On...Voir plusDernière mise à jour : il y a 4 jours
Associate Director of Student Affairs (52638)

Associate Director of Student Affairs (52638)

International Education CorporationOntario, CA
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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
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Medical Director / Physician

Medical Director / Physician

Drip Club INC.ON, Canada
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Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features.Medical Director / Physician (Virtual Consults). IV Therapy & Wellness Practice.Remote (Virtual Consult...Voir plusDernière mise à jour : il y a 10 jours
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Director Medical Affairs

Director Medical Affairs

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Our client is a clinical-stage biotechnology company focused on developing locally delivered, extended-release pharmaceutical products to address areas of high unmet medical need.Utilizing propriet...Voir plusDernière mise à jour : il y a 1 jour
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Medical Affairs Director, Orthopaedics

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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 10 jours
Manager, Regulatory Affairs

Manager, Regulatory Affairs

Innomar StrategiesRemote, ON
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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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Clinical Database Developer

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Regulatory Affairs Manager (Part-Time, Canada Based)

Regulatory Affairs Manager (Part-Time, Canada Based)

Advanced Clinicalnewmarket, on, Canada
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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 2 jours
Director, Communications And Public Affairs

Director, Communications And Public Affairs

Meridia Recruitment SolutionsOntario
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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

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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
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Compliance & Regulatory Affairs Manager

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Senior Medical Manager, Liver Diseases

Senior Medical Manager, Liver Diseases

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

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

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Temps plein
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Medical Laboratory Technologist

Medical Laboratory Technologist

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Quick Apply
Alexandra Hospital, Ingersoll is actively seeking applicants for a Medical Laboratory Technologist position.Certification with Canadian Society for Medical Laboratory Science or equivalent.Current ...Voir plusDernière mise à jour : il y a plus de 30 jours
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Regional Medical Director

Regional Medical Director

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Are you passionate about driving excellence in veterinary care and supporting the professional growth of veterinary teams? Do you love animals and the people who love them? NVA Canada is looking fo...Voir plusDernière mise à jour : il y a 14 jours
Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Apotex Inc.Golden Horseshoe, ON, Canada
Il y a 29 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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