Regulatory Affairs Specialist

Taro-sun pharma is seeking a Regulatory Affairs Associate/Specialist to join its R&D and Regulatory Affairs Department.

Responsibilities:

• Prepare regulatory submissions and registration dossiers for the FDA and other international markets.
• Respond to deficiency letters and regulatory authority inquiries.
• Submit and manage post-approval product variations and changes.
• Support regulatory compliance activities throughout the product lifecycle.

Requirements:

• Bachelor's degree in Pharmacy, Life Sciences, or a related field (required).
• Previous experience in regulatory dossier submissions and registrations (advantage).
• Proficiency in Microsoft Office applications.
• Excellent English communication skills, including writing, reading, and speaking.
• Strong written and verbal communication abilities.
• High level of organization, accuracy, and attention to detail.
• Ability to work effectively in a team environment and collaborate with cross-functional stakeholders.