Regulatory Affairs Officer

This role is for one of the Weekday's clients

Salary range: Rs 300000 - Rs 800000 (ie INR 3-8 LPA)

Min Experience: 3 years

Location: India, Hyderabad

JobType: full-time

Requirements

Key Responsibilities:

Drug Master Files (DMF):

• Prepare, compile, and review US DMFs (Type II), EU ASMFs, and other region-specific dossiers.
• Manage lifecycle activities such as updates, deficiency responses, and annual reports.
• Collaborate with internal teams to gather technical documents for submissions.

Regulatory Documentation & Submissions:

• Compile CTD/eCTD dossiers for global regulatory submissions (USFDA, EDQM, WHO, TGA, etc.).
• Ensure adherence to current international regulatory guidelines and standards.
• Maintain accurate records, document control systems, and submission archives.

Cross-Functional Collaboration:

• Coordinate with QA, QC, R&D, and Production teams for necessary documentation and technical inputs.
• Support preparation and review of product specifications, stability data, and Certificates of Analysis (COAs).

Audits & Inspections:

• Provide assistance during regulatory audits and inspections by international authorities and clients.
• Address regulatory queries and observations in a timely manner.

Regulatory Intelligence:

• Monitor and interpret updates in global regulatory guidelines (USFDA, EMA, ICH, etc.).
• Provide inputs on regulatory strategies, product classification, and compliance requirements.

Required Skills & Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
• 3–7 years of experience in Regulatory Affairs, preferably in pharmaceuticals, nutraceuticals, or herbal formulations.
• Strong understanding of DMF/ASMF preparation and submission processes.
• Familiarity with global regulatory frameworks (USFDA, EMA, TGA, WHO, etc.).
• Excellent documentation, communication, and organizational skills.
• High attention to detail with the ability to manage deadlines effectively.