Regulatory affairs - API

This role is for one of the Weekday's clients

Min Experience: 3 years

Location: Thane

JobType: full-time

We are seeking an experienced Regulatory Affairs Executive – API to manage regulatory documentation and submissions for active pharmaceutical ingredients (APIs). The role focuses on ensuring compliance with global regulatory requirements through accurate preparation, review, and timely submission of regulatory dossiers.

Key Responsibilities

• Compile, prepare, and review regulatory documents including DMF, DCP, EDMF, and CEP for API products.
• Ensure timely submission of regulatory dossiers in line with applicable regulatory guidelines and timelines.
• Coordinate with internal teams such as R&D, QA, QC, and Manufacturing to collect required data and ensure document accuracy.
• Maintain compliance with regulatory standards and respond to regulatory queries as required.
• Support ongoing and new regulatory filings related exclusively to API products.

Eligibility Criteria

Education

• Bachelor’s or Master’s degree in Science (B.Sc / M.Sc or equivalent).

Experience

• 4–5 years of experience in Regulatory Affairs, specifically within the API sector.

Industry Requirement

• Prior experience in an API-focused pharmaceutical environment is mandatory.

Level

• Executive

Key Skills

• Regulatory Affairs
• API Documentation & Submissions
• DMF / DCP / EDMF / CEP Handling
• Regulatory Compliance