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Regulatory affairs Offres d'emploi - Hamilton, ON

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Regulatory affairs • hamilton on

Dernière mise à jour : il y a 6 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 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
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Senior Product Manager, Edibles & Beverages

Senior Product Manager, Edibles & Beverages

Canopy Growth CorporationON, Canada
Temps plein
At Canopy Growth, our mission is clear : improve lives, end cannabis prohibition, and strengthen communities.We believe that cannabis can be a force for good. We’re building a consumer-centric organi...Voir plusDernière mise à jour : il y a 6 heures
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
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
assistant principal

assistant principal

Ashwood Glen SchoolBurlington, ON, CA
53,90 $CA par heure
Temps plein +1
Experience : 3 years to less than 5 years.Assure community participation in programs for a school district.Direct, through school principals, the academic affairs of a school district.Evaluate teach...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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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
Experience : 2 years to less than 3 years.Analyze and provide advice on the managerial methods and organization of an establishment. Develop quality management and quality assurance standards.Conduct...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
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Regulatory Affairs Associate

Regulatory Affairs Associate

Nora PharmaOntario, Canada, 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 8 jours
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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
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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 2 jours
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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 1 jour
Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Apotex Inc.Golden Horseshoe, ON, Canada
Il y a 27 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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