Regulatory Affairs Associate

Job description

Sain Medicaments Pvt Ltd – Hyderabad

About the Company :

Sain Medicaments Pvt Ltd is a leading pharmaceutical formulation company, proudly serving Human healthcare since 1970s, we have come a long way to make a mark in the healthcare industry which has ISO 22000 : 2005, WHO GMP, GLP certified manufacturing unit situated at HYDERABAD.

Opening for : Jr. Executive Regulatory Affairs

Job Duties :

• Preparation of regulatory dossier for various countries. Co-ordinate and collect data / Documents from various departments in plant and Review of the same for the compliance before preparation of dossiers.
• Contact API Vendors and manufacturers for DMFs / APIMFs / Tech packs. Review the documents and ensure its compliance as per the CTD requirements.
• Co-ordinate with graphic designer for labels and packaging material artworks development.
• Plan for samples for registration in co-ordination with concerned departments and ensure its readiness as per the submission plan.
• Handling of queries received from clients, drug authorities and ensure required further information / documents in stipulated timelines

Candidate should have knowledge of the following :

Experience :

Qualification :

Industry