Regulatory Affairs - Formulation Jobs in Rusan Pharma Ltd

Regulatory Affairs - Formulation - Rusan Pharma Ltd

Job Description 

Position Vacant Manager Regulatory Affairs

Organization Name RUSAN PHARMA LTD.

Company Profile Rusan is a research driven pharmaceutical company having its Manufacturing Units in India with 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 Drug Manufacturing (API) Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla with approval of MHRA (UK), MCC (SA) and other International Regulatory Authorities.

Job Description / Responsibilities Knowledge of Regulatory requirement for different countries (For Regulated/ Non Regulated Market)

10-20 year experience in Regulatory related work.
Knowledge of latest guidelines of all countries.
Responsible for Regulatory Dossier (ACTD or eCTD):
o Module 1to 5
Working with Operations for Publishing of the Dossier as per country requirements (eCTD/CTD/National Requirements).

Chair of Labelling Subteam 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.

- -Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines.

Should be able to handle team of regulatory.

Should have hands of experience in QC/QA/Production Dept.

Desired profile of the candidate B.Pharm / M.Pharm, B.Sc/M.Sc

RUSAN PHARMA LTD.
PLOT NO. 58 D, GOVT. INDUSTRIAL ESTATE, CHARKOP,
KANDIVLI (WEST), MUMBAI 400 067.
Email id hrmumbai@rusanpharma.com
Website http://www.rusanpharma.com

Keyskills

Desired Candidate Profile

Education-

Please refer to the Job description above

Company Profile: