2 meilleures offres (regulatory affairs specialist, richmond hill, on) (à pourvoir)

Regulatory Affairs Specialist (North America, LATAM, EU)
Alimentiv —Toronto, ON
- Temps plein
- Télétravail
- Espagnol
- Anglais
- Baccalauréat
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il y a 4 jours
Canada Senior Licensing Specialist Civil, Regulatory Affairs
GE Vernova —Markham, ON
- De 115 000 $ à 165 000 $ par an
- Temps plein
- Ingénierie
- Maîtrise
- Baccalauréat
- Indemnité de déménagement

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Canada Senior Licensing Specialist Civil, Regulatory Affairs
GE Vernova —Markham, ON
Support preparation and submittal of Preliminary Safety Analysis Report (PSAR), Pre-Operational Safety Analysis Report (POSAR) and Final Safety Analysis Report…
De 115 000 $ à 165 000 $ par an

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Regulatory Affairs Specialist (North America, LATAM, EU)

Alimentiv -
Toronto, ON

Postuler rapidement

Détails du poste

Permanent | Temps plein
Il y a 4 jours

Profil recherché

Espagnol
Anglais
Baccalauréat

Description complète du poste

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.

Unit Management

Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites.
Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.

Client Services

As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client.

Regulatory Strategy Development

Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives.
Participate in specialized conferences/meetings to increase knowledge as needed.

Project Support

Regularly respond to registration requests and work with project teams to identify regulatory requirements.
Assist in the preparation of regulatory submissions and support summaries.
Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.

Qualifications

Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
The successful candidate will possess strong knowledge of LATAM clinical trial regulations.
Fluency in English and Spanish (written and verbal) required.

Working Conditions

Home-based
- Accommodations for job applicants with disabilities are available upon request.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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regulatory affairs specialist emplois - richmond hill, on

Regulatory Affairs Specialist (North America, LATAM, EU)

Canada Senior Licensing Specialist Civil, Regulatory Affairs

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Je souhaite recevoir la dernière alerte emploi pour les postes de ce type : regulatory affairs specialist (richmond hill, on)

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