Friday, April 15, 2022

RUSAN PHARMA – Walk-In Interviews for Multiple Vacancies in Regulatory Affairs on 16th Apr’ 2022

 Rusan Pharma Ltd. is a fully integrated global pharmaceutical company specializing in the treatment of ‘Addiction and Pain Management’. We offer a complete range of products for de-addiction and pain management in countries across the globe including Europe, UK, Russia, CIS, South Africa, Mauritius, Nepal and Myanmar. We are one of the largest suppliers of life saving drugs to various organizations such as NACO, UNODC, UNOPS, Global Fund and Ministries of health in various emerging markets. Since 1994, we have been diligently working towards making Opioid Substitution Treatment (OST), a widely accepted form of treatment in India. Towards achieving this objective, we work with all the stakeholders to help achieve the change.


 

Rusan Phama is having multiple job vacancies in Regulatory Affairs department for Mumbai location.

Job description:

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

 

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