Essential Duties and Responsibilities:

➢ Technical Expertise: Proven experience in preparing USDMF, CEP, ASMF, Customer DMF from

Scratch and maintaining ASMFs/DMFs and CEPs (initial submissions and variations). Able to

prepare Open part and closed part of API/Excipient.

➢ Regulatory Compliance: Ensure company products comply with relevant regulatory requirements,

such as USFDA, EMA, and local regulations.

➢ Submission Management: Prepare and submit regulatory documents to regulatory agencies.

➢ 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.

➢ Regulatory Agency Interactions: Communicate with regulatory agencies, such as the FDA, to





address questions and concerns.

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

submissions, approvals, and correspondence.

Skills :

▪ Must have positive knowledge of Regulatory documents Preparation.

▪ Must have good knowledge of Regulatory Research.

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

- Experience

2 - 8 Years

- No. of Openings

5

- Education

Graduate

- Role

Regulatory Affairs Executive

- Gender

[ Male / Female ]

- Job Country

India

- Type of Job

Full Time

- Work Location Type

Work from Office

- Face Interview Location

Lower parel

📌 Regulatory Affairs Executive (India)
🏢 Ivin Hr Services
📍 India