Senior Regulatory NPD Project Manager

APOTEX; Toronto; Vor Ort; CAD 96.000 - 134.000; Vollzeit

Benefits dieser Stelle

Disability accommodation

Bonus programs

Pension plan

Learning and development

Zusammenfassung

Apotex is seeking a Project Manager for New Product Development (Regulatory Affairs) to lead regulatory submissions, due diligence, and deficiency responses within the NPD portfolio. The role requires strong knowledge of regulatory requirements for new drug submissions, especially in Canada and the US, with emphasis on risk mitigation and stakeholder collaboration.

You will drive strategic regulatory activities, manage complex project timelines, and mentor peers while ensuring compliance with

Qualifikationen

• Strong knowledge of regulatory requirements for new drug submissions and related quality aspects.
• Excellent communication, presentation and interpersonal skills.
• Organisational skills with ability to manage priorities.
• Knowledge of Canadian and US regulatory guidelines.

Aufgaben

• Develop regulatory project strategy with risk mitigation.
• Recover projects at risk and lead regulatory submissions.
• Assess deficiencies and address them prior to submission.
• Develop deficiency response strategies with stakeholders to meet deadlines.
• Conduct due diligence of opportunities; identify regulatory risks.
• Support product launches with change proposals and documentation.
• Execute change control assessments and related submissions.
• Train peers and promote safe, collaborative work practices.
• Adhere to compliance programs and company policies.
• Perform other duties as assigned.

Kenntnisse

Regulatory submissions

Due diligence

Risk mitigation

Deficiency responses

Project leadership

Change control

MS-Office

Regulatory guidelines (Canada/US)

Regulatory strategy

Ausbildung

B.Sc. in chemistry or related field

Tools

MS-Office

Jobbeschreibung

Apotex is seeking a Project Manager for New Product Development (Regulatory Affairs) to lead regulatory submissions, due diligence, and deficiency responses within the NPD portfolio. The role requires strong knowledge of regulatory requirements for new drug submissions, especially in Canada and the US, with emphasis on risk mitigation and stakeholder collaboration.

You will drive strategic regulatory activities, manage complex project timelines, and mentor peers while ensuring compliance with