Regulatory Affairs Executive

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 good 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