Required for Regulatory Affairs officers - Winston HR Services | B.Sc, M.Sc, B.Pharm, M.Pharm

Winston HR Services is a HRD division launched by HR professional providing manpower recruitment & staffing services to Pharma, Chemical, Dyes, IT, Plastic, Engineering, Textile, Retail, Telecom, electrical & many more industries

Post: Regulatory Affairs Officers

Job Description

Good communication skills, competency to handle Regulatory profile.
Strong Regulatory knowledge, only Pharmacy candidates preferred.
Preparation / review and submission of new Drug Master Files / Registration Dossiers for filing with various RegulatoryAgencies.
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 theRegulatory 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

Additional Information
Experience: 3-6 years
Salary: no bar for the right candidate
Education: B.Sc, M.Sc, B.Pharm, M.Pharm (pleasing personality and excellent communication skills in English)
Location: Bavla, Ahmedabad