Regulatory Affairs Specialist

4 days ago

Pune, Maharashtra, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
Regulatory Affairs Specialist Job Description

Role Overview:

The Regulatory Affairs Specialist plays a vital role in ensuring compliance with international regulatory guidelines and country-specific requirements by preparing, reviewing, and maintaining regulatory documents.

This involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

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., certificates of analysis) 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.

Required Skills and Qualifications:

  • Graduate/Postgraduate degree 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:

As a Regulatory Affairs Specialist, you will have the opportunity to work in a dynamic environment, collaborate with cross-functional teams, and contribute to the success of our organization.

We offer a competitive compensation package, opportunities for professional growth and development, and a collaborative work environment.

What We Offer:

At our organization, we value innovation, teamwork, and customer satisfaction. We are committed to fostering a positive and inclusive work environment that supports the well-being of our employees.

How to Apply:

If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application, including your resume and a cover letter, outlining your qualifications and experience.

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