Senior Regulatory Affairs Specialist

Mendine Pharmaceuticals Pvt Ltd

0 years

0 Lacs

Kolkata West Bengal India

Posted:1 day ago| Platform:

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Skills Required

network cutting manufacturing research development integrity compliance tracking regulations monitoring remediation documentation audit communication writing presentation compensation diversity

Work Mode

On-site

Job Type

Full Time

Job Description

About the Company:

Job Objective :

Responsibilities

Responsible for monitoring regulatory changes, preparing and submitting documents to regulatory agencies, and providing guidance to internal teams on compliance.
This role also includes assessing compliance, recommending remediation, and acting as a liaison between the company and regulatory agencies.
Responsible for preparing and submitting various documents, including product registration dossiers, clinical trial documentation, Endorsement approval COPP product wise approval and other regulatory submissions.
Co-ordination for external audit with external Regulatory Agency with Regularity guideline awareness.

Qualifications

B. Pharm/M pharm/MSc.
Minimum 5-8 Yrs. Experience in RA

Preferred Skills

Regulatory Affairs roles require a blend of technical and soft skills.
Strong analytical and problem-solving abilities are crucial for interpreting regulations and addressing complex issues.
Effective communication, including writing and presentation skills, is essential for interacting with regulatory bodies and internal teams.
Additionally, strong skills are needed to coordinate submissions and ensure compliance with deadlines.

Pay range and compensation package

Equal Opportunity Statement

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