HEREO - Openings for Regulatory Affairs - Bulk Drugs / API @ Hyderabad

REGULATORY AFFAIRS/EXPERIENCE-BULK DRUGS/API-HYDERABAD

Department: Regulatory Affairs

Designation: Executive/Sr. Executive

Industry: Pharma/API

Experience: 2 to 6 years

CTC: Negotiable

Job Location: Sanath Nagar, Hyderabad

Roles and Responsibilities

Preparation of Drug Master Files (DMF) in CTD / eCTD / Nees format for US, European Countries, Canada, Australia, Japan, GCC, Turkey and Korea as per customer/ business requirement.
Preparation of amendments/ Annual Reports to USDMFs, CEP variations, EDMF Updates, Biannual updates to Canada DMFs and Annual updates to Korea DMFs, Japan DMFs.
Review and approval of change controls.
Submission of notifications to the customers pertaining to regulatory submissions as per the applicability.
Responding to deficiency letters received from various regulatory agencies like USFDA, EU Agencies, TGA, Health Canada etc.
Hands-on experience in Electronic submissions-Lorenz.
Maintaining query database and response timelines.
Tracking of variation submission timelines (Amendments, Annual Reports) to various Health Authorities
Responsible for organizing meetings to address queries and variation submissions.
Rendering customer support by preparing technical packages, Applicant" s Part Drug Master Files and responding to the technical queries received from customers.

Desired Candidates Please Share Your Updated Resume vivek.s@heterodrugs.com

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