Sun Pharmaceutical Industries Ltd is hiring for Sr.Executive Drug Regulatory Affairs (US / EU Markets)..Sun Pharma beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India.Application form link provided at the end of post.
Vacancy Details :
- Company Name: Sun Pharmaceutical Industries Ltd
- Location : Vadoadara
- Post Name: Sr.Executive Drug Regulatory Affairs (US / EU Markets)
- Qualification: M.Pharm
- Experience:2 to 3 Years experience in any of these US / EU Markets is a must
- No of Vacancies: NA
- Details of Salary: NA
- Mode of application : Online
- Selection Process: Personal interview
Job Description/Skills Required :
1. New Submissions: Work with Product Development (For Drug products) & other CFT (within and outside R&D) to ensure that sufficient and timely regulatory information and controls are included during design and development of drug products as per country specific regulatory requirements.a. Provide feedback in terms of document requirements & regulatory filing strategy during development of new DF (Drug formulation).b. Preparation and submission of good quality dossiers thereby enabling faster approvals and timely launch.c. Assist in preparation and submission of meeting packages/scientific discussion with Agency related to product development (if required).2. Approval: Prepare and submit timely response to deficiencies enabling approval of products.3. Lifecycle Management of approved drug products:a. Timely preparation and submission of annual reports/renewals.b. Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplies.c. Regulatory Compliance- Ensure timely implementation of regulatory decisions for changemanagement and other activities in DF plants.d. Ensure reposition of comprehensive product information into central repository.4. Self-Development:a. Reading regulatory guidelines, participating and delivering presentations.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
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