Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist 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 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.
Pay: ₹40,000.00 - ₹50,000.00 per month
Benefits:
- Health insurance
- Life insurance
- Provident Fund
Work Location: In person
