Regulatory Affairs Manager

Novo Medi Sciences (Novo Group) is a leading pharmaceutical company dedicated to innovation and excellence, with having more than 75 years of presence in the healthcare sector. We are committed to delivering cutting-edge solutions and improving lives through pioneering the introduction of life saving critical care molecules & vaccines in India.

Role Overview:

We are seeking a dynamic and experienced professional for the position of Regulatory Affairs – Manager. 

Qualification: B Pharm / M Pharm.

Location:- Dadar East, Mumbai, Maharashtra.

Experience: - Minimum 10 years of thorough experience in below given JD.

Reporting structure: Reporting – MD.

Job Description:

• Expertise of compiling & reviewing ACTD, CTD dossiers of Finished formulation for non-regulated & Semi regulated markets..
• Reply queries raised by MOH of relevant Territory on dossiers submitted.
• Checking art works and samples of the products and ensure compliance.
• Interaction and coordinating with international agent for dossier submission and registration status
• Maintain Product's Lifecyle and all records of technical documentations, registrations.
• File variations and renewals of Products.
• Team Handling experience