Regulatory Affairs Associate at Sun Pharma

Enhance your career in regulatory affairs with Sun Pharma as an Associate. This hybrid role focuses on preparing drug submissions for the US FDA and Health Canada.

The position involves filing various regulatory submissions, including eCTD formats for numerous dosage forms. As a key player in product registrations, you will also respond to agency inquiries and maintain compliance with approved product monographs. The role combines scientific knowledge with regulatory expertise, ensuring our medications reach patients efficiently.

Key Responsibilities:

• Prepare drug product submissions for FDA and Health Canada

• Review submissions in eCTD format for accuracy

• Respond to regulatory deficiency letters promptly

• Maintain approved product monographs in compliance

• Assist with global drug registrations as needed

Requirements:

•

B.Sc. in Chemistry, Pharmacy, or Life Sciences

• 3-5 years of experience in Canadian/USA Regulatory Affairs

• Familiarity with eCTD submissions preferred

• Strong knowledge of regulatory guidelines

• Proficient in Microsoft Office and Adobe Acrobat

Elevate your regulatory skills and support critical drug submissions with Sun Pharma.
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