Executive Regulatory Affairs

☞ INTEGRATED PERSONNEL SERVICES LIMITED

Ver: 106

Dia de atualização: 06-05-2024

Localização: Mumbai Maharashtra

Categoria: Farmacêutico / Químico / Biotecnologia Saúde / Assistência Médica Farmacêutico / Representantes farmacêuticos

Indústria: Pharmaceutical & Life Sciences

Posição: Regulatory Affairs Manager

Tipo de empregos: Full Time, Permanent

Salário: ₹ 2,00,000 - 5,00,000 P.A.

Experiência: 1 - 5 years

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Conteúdo do emprego

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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Data limite: 20-06-2024

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