Designation: Regulatory Affairs - Assistant Manager (Europe Market).

Qualifications: Bachelor's degree/ Masters degree in a scientific discipline, such as

pharmacy, biology, or chemistry.

Experience: Minimum 4 years of experience in RA in API/Excipient (Europe).

Job Location: Lower Parel.

Job Summary

We are seeking a highly skilled Regulatory Affairs - Assistant Manager (Europe Market) to

join our team. The successful candidate will be responsible for ensuring compliance with

regulatory requirements for our products, managing the submission process for regulatory

approvals, and maintaining up-to-date knowledge of regulatory changes.

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.

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