Regulatory Affairs - Assistant Manager

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.

• Experience

  4 - 8 Years

• No. of Openings

  1

• Education

  Graduate

• Role

  Manager Regulatory Affairs

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office

• Face Interview Location

  Lower parel