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Spécialiste, Affaires réglementaires / Regulatory Affairs Specialist at Jubilant DraxImage Inc

Montréal, QC, Canada -

Full Time

Start Date

Immediate

Expiry Date

29 Nov, 25

Salary

0.0

Posted On

30 Aug, 25

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Good communication skills

Industry

Pharmaceuticals

Description

Responsibilities

Act as a regulatory expert for cross-functional teams including R&D, Manufacturing, Quality Assurance, Marketing, and Clinical Affairs.
Prepare and submit pharmaceutical and technical documentation for clinical trials, product marketing, and updates to existing products.
Analyze regulatory requirements and assess the compliance of data and procedures.
Draft technical summaries, labeling, and electronic submissions for Health Canada, FDA, and other international authorities.
Ensure ongoing compliance by managing post-approval changes and establishment registrations.
Recommend adjustments to clinical protocols, labeling, or manufacturing to maintain regulatory compliance.
Contribute to cross-functional projects and continuous improvement of regulatory processes.