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