Rusan Pharma Ltd. Job Vacancy For Regulatory Affairs

Rusan Pharma Ltd. Job Vacancy For Regulatory Affairs

Rusan Pharma Ltd. Job Vacancy For Regulatory Affairs

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

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