Job Description

Essential Duties and Responsibilities:

? Technical Expertise: Proven experience in preparing CEPs/ASMFs from Scratch,

submitting, and maintaining ASMFs/DMFs and CEPs (initial submissions and variations)

to the EDQM and/or European National Competent Authorities.

? Regulatory Compliance: Ensure company products comply with relevant regulatory

requirements, and local regulations.

? Software: Familiarity with electronic submission systems and validation software like

Pharmaready, Lorenz.

? Document Preparation: Proven ability to independently prepare Modules I, II, and III

of APIs and Excipient.

? Login/Account Creation: Having knowledge to make Company Login/Account Creation

on all Countries Regulatory Portals.

? Regulatory Strategy: Develop and implement regulatory strategies to support product

development and commercialization.

? Regulatory Intelligence: Stay up-to-date with changing regulatory requirements and

provide guidance to internal stakeholders.

? Audits and Inspections: Coordinate and manage regulatory audits and inspections.

? Regulatory Agency Interactions: Communicate with regulatory agencies, such as the

EMA, EDQM, FDA, to address questions and concerns.

? Regulatory Documentation: Maintain and manage regulatory documents, such as

regulatory submissions, approvals, and correspondence.

? Training and Guidance: Provide regulatory training and guidance to internal

stakeholders.

? Compliance Monitoring: Monitor company activities for compliance with regulatory

requirements.

? Advantage: It would be a significant asset to possess skills in preparing and submitting

DMFs/Master Files/Submissions to regulatory bodies in regions including Europe/UK,

Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, and Mexico.

Skills :

? Must have good knowledge of Regulatory Submissions and Preparation.

? Must have good knowledge of Regulatory Research.

? Must be familiarity with chemical industry specific regulations and guidelines.

Job Types: Full-time, Permanent

Pay: ?50,000.00 - ?90,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person