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.

Interested candidates can send your updated profile  with below mentioned details.

Total Experience

Relevant experience

Current CTC

Expected CTC

Notice Period

Reason for job change

Thanks & Regards

K Pavithra

Sr. HR Recruiter

AARNA HR SOLUTIONS

9513802563