Executive Regulatory Affairs

☞ INTEGRATED PERSONNEL SERVICES LIMITED

View: 106

Update day: 06-05-2024

Location: Mumbai Maharashtra

Category: Pharmaceutical / Chemical / Biotech Health / Medical Care Pharmacist / Pharmaceutical representatives

Industry: Pharmaceutical & Life Sciences

Position: Regulatory Affairs Manager

Job type: Full Time, Permanent

Salary: ₹ 2,00,000 - 5,00,000 P.A.

Experience: 1 - 5 years

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Job content

Roles and Responsibilities :


Dossier preparation for eCTD market UK , EU , Australia & Newzealand & VARIATION filing in EU/Australia market

New project Execution , Should review MFR,PDR,BMR,PVR,SPECS MOA ,STABILITY , ERA,NDMA. Should have knowledge of product lifecycle management

RFI Response , customer queries

Should be well versed with EMEA, TGA and ICH Guidelines. Should visit site for required documents for dossier submission and RFI response as and when required

Should be strong in communication and correspondence.

Desired Skills:

Quality , RND (Product development), Dossier Preparation eCTD format. Very well versed with EMEA Guidelines

Efficient Problem solving , Effective communication, creative thinking , Should be Bold /challenge seeker, positive attitude



Desired Candidate Profile



Perks and Benefits



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Deadline: 20-06-2024

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