Quick Overview
Job Description
Greeting!!
Aarna HR Solutions is a Human Resource Recruitment Company providing services to Various IT, ITES and Non- IT companies across India. Aarna Solutions strive towards hiring the best and the brightest talent in the industry. We hire individuals with a strong sense of pride in their performance, team spirit, and a desire to excel.
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
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