Regulatory Affairs - Rusan Pharma LTD - Gandhidham Location

☞ Rusan Pharma Ltd

Visualizza: 107

Giorno di aggiornamento: 30-05-2024

Località: Gandhidham Gujrat

Categoria: Legale / Contratti

Industria: Biotechnology Research Hospitals Health Care Pharmaceutical Manufacturing

Posizione: Entry level

Tipo di lavoro: Full-time

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Contenuto del lavoro

Hello,

There is an opening for "Regulatory Affairs" with RUSAN PHARMA LTD (R&D center) at Gandhidham Location.

B Pharma / M Pharma with 3-9 years of Experience in preparing and submission of dossiers as per country requirement (Semi Regulated/ROW Countries)

Job Location : Gandhidham - Kutch Location (Candidates should be ready to relocate Gandhidham Location)

Job Role

Working with Operations for Publishing of the Dossier (Independently Module 1- 5) as per country requirements (eCTD/CTD/National Requirements).

Chair of Labelling Sub team Meetings (LST) which includes Subject Matter Experts from Medical Affairs, Pharmacovigilance, Clinical Development and Nonclinical Development.

Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities.

Knowledge of Preparation & compilation and reviewing the documents which is coming from manufacturing site for the preparation of dossiers for various countries along with legal documentations.

Tender file Preparation, as per the bid documents.

Regulatory activities include pre licensing activities, new registration of products, post licensing regulatory submissions, interaction with health authorities of respective countries.

Best Regards

Priti Singhvi

RUSAN PHARMA LTD - Gandhidham Location (R&D center)

Corporate HR

Direct Line : 022-42383063

priti.singhvi@rusanpharma.com

,

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Scadenza: 14-07-2024

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