RA Executive - Canada, Australia, Maxico

Executive to Senior Executive - Regulatory Affairs

Canada | Mexico | Australia

Location: Vadodara, Gujarat, India

Department: Regulatory Affairs

Job Overview:

We are looking for Regulatory Affairs professionals to manage regulatory submissions, product registrations, and lifecycle activities for the Canada, Mexico, and Australia markets. Each vacancy will focus on one specific market.

Key Responsibilities

• Prepare and coordinate regulatory submissions, product registrations, variations, and renewals.
• Compile and review regulatory documents to ensure accuracy and compliance.
• Handle regulatory queries and deficiency responses.
• Coordinate with cross-functional teams and international partners.
• Manage submission timelines, project trackers, and post-approval activities.

Market-Specific Requirements:

• Canada: Knowledge of Health Canada regulations, NDS, ANDS, and DIN applications.
• Mexico: Knowledge of COFEPRIS regulations, product registrations, renewals, and variations.
• Australia: Knowledge of TGA regulations, regulatory submissions, variations, and lifecycle management

Qualification:

Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.