Regulatory Affairs Executive

Business: PPL
Department: Regulatory Affairs
Location: Navi Mumbai
Travel: Low

The role involves maintaining regulatory databases, supporting document compilation, and coordinating required documentation for regulatory submissions, amendments, and license applications with FDA and CDSCO. The position also includes preparing Letters of Access and performing other duties as assigned by the Head of Department.

Key Responsibilities:

• Maintaining and updating database to track the submissions.
• Support for document compilation for Applicant's part.
• Preparation of Letter of Access.
• Collection of documents for Annual updates, Amendments and CEP Amendments.
• Collection of documents for License applications to FDA and CDSCO.
• Any other work assigned by HOD/Designee.

Preferred candidate profile:

• Masters/bachelor’s degree in chemistry or a related field.
• Basic understanding of peptide synthesis principles is a plus.
• Strong attention to detail and commitment to quality.
• Ability to work in a team-oriented environment.
• Good communication and interpersonal skills.
• Willingness to learn and adapt to new processes.