Regulatory Affairs Expert

2 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

Job Title: Regulatory Affairs Specialist

 

Objective:

The ideal candidate will prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.

Key Responsibilities:

  • Screen and analyze documents received for product registration requests as per country-specific guidelines.
  • Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  • Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Arrange supportive batch-related documents (e.g., DOC, COA) for registration samples.
  • Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices.
  • Support the Compliance team by providing updated documents required for technical file preparation.
  • Periodically review and update Technical Master Files to ensure consistency across product categories.
  • Coordinate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
  • Ensure timely preparation and submission of documents related to audit findings.
  • Adhere to departmental priorities and provide support for additional tasks as assigned.

 

Requirements:

Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline.

3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.

Strong understanding of global regulatory guidelines and dossier preparation.

Detail-oriented, with excellent organizational and analytical skills.

Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.

Good written and verbal communication skills.

 

Benefits:

Opportunity to work in a dynamic environment with a dedicated team.

Professional growth and development through training and mentorship.

Competitive compensation package.

 

Apply Now:

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, please submit your application.

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