Regulatory Affairs Specialist

PHARMASTARS

Prepare, review, and submit regulatory documentation for Pharmaceutical products, Dietary Supplement products and Medical Devices to Regulatory authorities in accordance with applicable regulations and guidelines.

• Prepare & Follow-up of files submission to various committees until receiving final approval.
• Monitor and interpret evolving regulatory requirements to ensure ongoing compliance for all products and processes.
• Pre-formulation research for new pharmaceutical products.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing to support regulatory strategies and submissions.
• Maintain up-to-date records of all regulatory submissions, approvals, and correspondence with authorities.
• Coordinate responses to regulatory queries and deficiency letters in a timely and accurate manner.
• Provide regulatory input during product development, labeling, and promotional material review.
• Support internal audits and inspections by regulatory agencies, ensuring readiness and compliance.
• Track and manage product registrations, renewals, and variations.
• Assist in the development and implementation of regulatory policies and standard operating procedures.
• Stay informed of industry trends and best practices to proactively address potential regulatory challenges.
• Applying the company policies and work for achieving its goals according to the ethics, rules & regulations.