Junior Executive - Regulatory Affairs

About the Position:

The Regulatory Affairs Executive assists other members of Regulatory Affairs Team in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and standards. The Regulatory Affairs Executive is an individual contributor who works independently, applies regulatory domain knowledge and leads continuous improvement of processes and tools/systems. 

Responsibilities:

1. Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
2. Take the necessary measures to ensure compliance with the planned timing of new product registration, renewals of various products.
3. Consistently exercises good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems
4. Understands and applies regulatory standards, guidance’s, promotional guidelines, and regulations.
5. Complete gap analysis on registration dossiers to ensure they comply with government regulations prior to submission.
6. Communicate key topics and relevant issues timely and proactively to the manager and relevant line functions.

Requirements:

1. Education: B.Pharm/ M.Pharm
2. Preferred: Specialty Degrees in Formulation & Development, Pharmaceutical Technologies
3. Experience: Minimum Experience of 1-3 years in Regulatory Affairs in Solid Oral Dosage Forms. Work experience in Quality Control and R&D will be also considered as a plus.