Regulatory Affairs Officer

3 weeks ago

Hyderabad, India Weekday AI Full time

This role is for one of the Weekday's clients

Salary range: Rs Rs 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.

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