Senior Officer, Regulatory Affairs

Job Description

Title: Senior Officer, Regulatory Affairs

Company Name: RRP Pharmaceutical, Ishwardi, Pabna

Vacancy: 01

Job Location: Pabna (Ishwardi)

Employment Status: Full-time

Educational Requirements:
∎ M Pharm/B Pharm from reputed University.

Experience Requirements:
∎ At least 3 year(s)

Job Responsibilities:
∎ Able to run the Regulatory Affairs activity of RRP Pharmaceutical, confirming GMP regulations.
∎ Knowledge about regulatory requirements.
∎ Keeping up to date with changes in regulatory legislation and guidelines.
∎ Offering advice about regulations, company policies, practices and systems.
∎ Obtaining marketing permission.
∎ Liaising and negotiating with regulatory authorities.
∎ Study scientific and legal documents to check that documents meet legal requirements.
∎ Planning, undertaking and overseeing product trials and regulatory inspections.
∎ Regularly visit to pharma plant as per instructions and guidelines and report to the concern person.
∎ Review and clearance of technical documents leading to dossier batches executions and registrations.
∎ Compilation of analytical technical documents for dossier / Technology transfer / Regulatory submissions of projects.
∎ Communicating and coordinating with different departments time to time for smooth operation of the departments.
∎ Clear knowledge on documentation of QA/QC/Production Department.
∎ Maintain professional and technical knowledge.
∎ Should be smart, dynamic and proactive with positive thinking approach.
∎ Any other tasks as assigned by management when required.

Additional Requirements:
∎ At least 3 years in Regulatory Affairs Department
∎ Proficiency in speaking and writing English.
∎ Good computer knowledge.
∎ Must be able to work under pressure.

∎ As per organization`s policy

Compensation & Other Benefits:
∎ As per organization's policy

Job Source: Online Job Posting.

Application Deadline: 19 Dec 2023

Company Information:
∎ 19 Nov 2023
∎ RRP Pharmaceutical, Ishwardi, Pabna

Category: Medical/Pharma



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