Qualifications : Minimum Bachelor's degree in a scientific discipline, such as pharmacy, biology,

or chemistry.

▪ Experience : Minimum 2 years of experience in RA in API/Excipient.

▪ Salary : Valuable Hike on Current CTC

▪ Location : Lower Parel

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 upto-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: ₹342,000.00 - ₹500,000.00 per year

Benefits

- Provident Fund

Experience:
- Excipient: 2 years (Preferred)
- Active Pharmaceutical Ingredient (API): 2 years (Preferred)
- DMF (Drug Master File) : 2 years (Preferred)
- Chemical & Farma Industry : 2 years (Preferred)

Work Location: In person

📌 Regulatory Affairs Executive ( API/Excipient) (Parel)
🏢 MUBY CHEM PRIVATE
📍 Parel