Executive Regulatory Affairs

☞ INTEGRATED PERSONNEL SERVICES LIMITED

Vue: 106

Jour de mise à jour: 06-05-2024

Localisation: Mumbai Maharashtra

Catégorie: Pharmaceutique / Chimique / Biotechnologie Santé / soins médicaux Pharmacien / Représentants pharmaceutiques

Industrie: Pharmaceutical & Life Sciences

Niveau: Regulatory Affairs Manager

Type d’emploi: Full Time, Permanent

Salaire: ₹ 2,00,000 - 5,00,000 P.A.

Expérience: 1 - 5 years

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le contenu du travail

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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Date limite: 20-06-2024

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