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