Regulatory Assistant Manager / Manager at Andheri.

Job Description

Urgent job opening of Regulatory Assistant Manager / Manager for Pharmaceutical Company at Andheri East. Requirement: 2 opening Job Profile: 1) Ensure that the company's products comply with the regulations of the regions where they are distributed. 2) Keep up to date with national and international legislation, guidelines and customer practices. 3) Prepare dossiers, documents and samples as per requirement of markets for participation in tenders. 4) Collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats, experience in west African markets shall be an additional advantage . 5) Monitor and set timelines for registrations variations and renewal approvals and submissions. 6) Write clear, accessible product labels and patient information leaflets. Advise country sales managers on regulatory requirements. 7) Provide strategic advice to senior management throughout the development of a new product. 8) Manage teams of colleagues involved with the development of new products. Undertake and manage regulatory internal audits .. 9) Review company practices and provide advice on changes to systems. 10) Liaise with, and make presentations to, regulatory authorities. 11) Follow up with marketing team for marketing authorization, registration data and status. 12) Take part in the development of marketing concepts and approve packaging and advertising before a product's release. 13) Experience in coordination with third party manufacturing units for contract manufacturing of various products as per the requirement. If you are interested for the above referred position, kindly revert back with your Updated Resume with Photograph along with following details: 1) Current salary 2) Expected salary 3) Notice period 4) Total experience 5) Relevant experience 6) Current location 7) Reason for job change Contact no.:- Sakshi - 8591939527 Mail ID:- sakshi@jobsearchindia.in