Regulatory Affairs Specialist - Dietary Supplements

PHARMASTARS

Deal with NFSA & EDA Regulatory Authorities in Egypt concerning Dietary Supplements

Prepare, compile, and submit regulatory dossiers for product registration and renewals.

Monitor and interpret regulations, guidelines, and updates to ensure ongoing compliance.

Prepare, review, and submit regulatory documentation in accordance with applicable regulations and guidelines.

Prepare & Follow-up of files submission until receiving final approval.

Monitor and interpret evolving regulatory requirements to ensure ongoing compliance for all products and processes.

Maintain up-to-date records of all regulatory submissions, approvals, and correspondence with authority.

Coordinate responses to regulatory queries and deficiency letters in a timely and accurate manner.

Pre-formulation research for new pharmaceutical products.

Collaborate for product development & labeling

Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing to support regulatory strategies and submissions.

Track and manage product registrations, renewals, and variations.

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.