Roles and Responsibilities :

- Preparation, review and maintain regulatory submission documentation
- Preparation, review and maintain other documentation like CMC & technical data package.
- Technical review of technology transfer document
- Exposure for handling of queries received from different regulatory agencies.
- Exposure of eCTD format and Exposure of various regulatory filling
- Exposure current requirements of various regulatory authorities
- Exposure for handling of technical query received from customer
- Exposure for handling of different questionnaire received from customer
- Exposure of communication with various regulatory authority directly
- Exposure of communication with customer directly with respect to regulatory queries
- Knowledge of FEI registration, DUNS registration,



SPOR data base management etc.
- Exposure of review of quality agreement or supplier agreement.

Job Requirements :

- B.Sc. or M.Sc Chemistry/Organic Chemistry.
- 5-7 years of experience in Regulatory Affairs within API, Pharma Intermediate, or Specialty Fine Chemicals manufacturing environment.
- In-depth knowledge of ICH guidelines, cGMP, and global chemical regulations (REACH/GHS).
- Solid technical writing and document preparation skills.
- Exceptional cross-functional coordination and communication skills to deal with internal team as well international clients and regulatory agencies.

📌 Regulatory Affairs Executive (Surat)
🏢 ACUTAAS CHEMICALS
📍 Surat