Manager - Regulatory Affairs

We have immediate openings for “Manager – Regulatory Affairs” one of our Reputed Client for Hosur location.

About Position:-
Position: “Manager – Regulatory Affairs "
Qualification: BSC / MSC
Experience: 8 - 10 years (Bulk drugs / API)
Location: Hosur

Responsibilities:

• Preparation & Review of drug master file/ Common Technical Document of various Drug substances.
• Preparation and submission of Technical Packages/ Product Dossiers.
• Preparation of Declaration of Access and Letter of Access, Letter of Commitment, Letter of Engagement, Submission Letter.
• Handling of deficiencies from the regulatory agencies as well from customers.
• Preparation and submission of Quality Questionnaires and related documents receive form customers.
• Co-ordination with QC, QA, Stores, Production and R&D with respect to Regulatory requirements.
• Marketing support.
• Preparation and submission of documents for Drug License, Written Confirmation, NOC,FSSAI License, Free Sale Certificate, GMP Certificate
• Any other activity assigned by the department head.
• Improvement , periodic review and updation of current SOPs and work systems.
• To ensure the sourcing material, manufacturing and testing is carried out as per dossier, accepted for registration by concern regulatory agency. Preparation of documents required for regulatory affairs.
• To monitor Qualification of new/modified areas/equipments and also ensure their requalification
• Reviewing technical agreement and Quality agreement.