Regulatory Affairs Specialist

7 hours ago

Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

Regulatory Document Specialist Role Overview

Job Description

Prepare and manage regulatory documents, such as DMF/ASMF/CEP dossiers, in compliance with ICH M4 CTD/eCTD guidelines. This involves reviewing and revising documentation to ensure accuracy and adherence to regulatory requirements.

Key Responsibilities
  • Prepare responses to queries from regulatory agencies and customers, demonstrating a thorough understanding of the relevant regulations and guidelines.
  • Collaborate with cross-functional teams to gather information and input for document preparation.
  • Review and update standard operating procedures (SOPs) to ensure alignment with regulatory expectations.
  • Identify and initiate corrective actions for any deviations or discrepancies in documentation.
  • Develop and maintain knowledge of current global regulatory requirements to inform document preparation and updates.
Required Skills and Qualifications

Strong analytical and problem-solving skills, with attention to detail and ability to work independently.

Excellent communication and interpersonal skills, with experience working with diverse stakeholders.

Proficiency in MS Office applications, with strong organizational and time management skills.

Benefits

This role offers opportunities for professional growth and development, with a focus on regulatory compliance and document management expertise.

Others

We are committed to creating a workplace culture that values diversity, equity, and inclusion. If you are passionate about regulatory affairs and have a strong work ethic, we encourage you to apply.

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