Regulatory Affairs Jobs Pharma (API) in Cadila Healthcare Limited

By: Pharma Jobs | Views: 3022 | Date: 25-Dec-2014

Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group's operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets.



Opening for Regulatory Affairs Officer to Sr.executive - Pharma (API) @ Ankleshwar




Cadila Healthcare Limited

2 - 7 yrs 
Ankleshwar

Job Description

    Preparation / review and submission of new Drug Master Files / Registration Dossiers for filing with various Regulatory Agencies.

    Preparation / review and submission of Annual updates, Renewal Dossiers, Amendments / Variation dossiers for filing with various Regulatory Agencies.

    Preparation / review of response to Regulatory Agencies / customer queries.

    Review, approval and closure of Change control and ensure that the changes are appropriately communicated to the Regulatory Agencies / customers.

    Provide Technical Data Packages / Open Part of DMFs complying with customer specific requirements to customers.

    Review of analytical method validations and other R&D documents intended for DMFs submissions.

    Plan and coordinate with various departments like R&D, QA, Manufacturing, Marketing and Supply chain so as to project the document requirements for appropriate submissions.

    Review and approval of Regulatory specifications.

    Ensuring Pharmacopoeial compliance.

    Should have good knowledge on ICH and other Regulated market guidelines and RA - Departmental Profile

Salary:Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Other

Role Category:Other

Role:Other

Keyskills

regulatory affairs officer or sr.executive

Desired Candidate Profile

Education-

UG:B.Sc - Any Specialization, B.Pharma - Pharmacy

PG:M.Sc - Any Specialization, Chemistry, M.Pharma - Pharmacy

Doctorate:Doctorate Not Required

    Cadidate should be technically qualified & having exposure of Pharma (API) unit. He should be competent in Regulatory activities & have good command on GMP, cGMP, GLP & Pharmacopoeial compliance. Should have good knowledge on ICH and other Regulated market guidelines.Review and approval of Regulatory specifications.

Company Profile:

Cadila Healthcare Limited

Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group's operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets.

In its mission to create healthier communities globally, Zydus Cadila delivers wide ranging healthcare solutions and value to its customers. With over 9,000 employees worldwide, a world-class research and development centre dedicated to discovery research and eight state-of-the-art manufacturing plants, the group is dedicated to improving people's lives.

Recruiter Name:Mayur Dalal - 9725211170

Email Address:mayurdalal@zyduscadila.com

Website:http://www.zyduscadila.com

Telephone:02646660507


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Comments
Siva  |  30-Dec-2014 09:34:43 IST
B pharm completed fresher.originals not given quilify or not
Md.Imran Ahmad  |  03-Jan-2015 18:06:43 IST
Hi i am imran i am graduated with bachlor deegree of science(physics)i have well exprience in retail field and motivating the other sales personal to achive the goal of compny.now i am looking MR job in medicine company .so pls hle me
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