Rusan Pharma Walk-in 16th April 2022 for Regulatory Affairs

Rusan Pharma Walk-in Interview 2022 Any UG  for Regulatory Affairs At Mumbai . Rusan Pharma Notification full details below..Interested and eligible candidates Send Your Resume On Hr mail.

• Vacancy details:
• Department :  Regulatory Affairs
• Qualification: Any UG
• Experienced: Experience
• Openings:NA
• Salary:NA

Job Description: Rusan Pharma Hiring For Chemist to officer – Regulatory Affairs ! There is an opening for Chemist to officer – Regulatory Affairs for Rusan Pharma ltd at our Gandhidham (Kandla) Location

• Important Details :
• Location: Mumbai
• Contact:Board Line: 022 42383000 / 42383063
• Note:Interested Candidates can share their CV to shalini.singh@rusanpharma.com
• Post of date:15/04/2022
  
• Selection Process: The selection will be on the basis of Interview.
• Walk-In Date: 16th April, 2022
  Time: 10.00 AM – 5.00 PM
  Venue:
  Rusan Pharma Ltd.
  58-D, Government Industrial Estate, Charkop, Kandivli (W),
  Mumbai – 400 067
  Board Line: 022 42383000 / 42383063

Roles and Responsibilities

Countries: Australia / New Zealand/ Canada/ Brazil /Mexico/ CIS countries/ Europe/UK

1. Responsible for Dossier compilation:

• To prepare new, renewal dossier (Semi Finished/ Finished Product) and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for South Africa and Brazil filing and Regulatory knowledge of Guidelines viz, ICH , FDA PICs etc.
• To review accuracy of executed data before submission – Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
• To review of documents for adequacy and accuracy.
• To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
• To arrange the samples as per country requirements.

2. Responsible for Tender compilation:

• To gather, evaluate, organize, manage and collate information/ documents requirements for Tender fillings for WHO.

3. Ensure timely delivery of regulatory query:

• To review and ensure accuracy of deficiency response for Quality, Clinical part of dossier.
• To evaluate the query received for registered or under registration products and Tender products and also to support for completion of the same in timely manner.

4. Compliance (Audits / Audit Readiness)

• Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.

Desired Candidate Profile:

Candidate must have prior experience in dossier preparations, review and submission for Australia / New Zealand/ Canada/ Brazil /Mexico/ CIS countries/ Europe/UK.

Interested candidates can share their profile at shalini.singh@rusanpharma.com

About Company:

Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 – 82 Crs., Expected by March 2009 €“ 150 Crs.