Regulatory Affairs Executive

7 days ago

India Biotech Healthcare Full time

Role Objective

Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

Desired Candidate Profile

  • 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.

Roles & 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.

Functional Skills Required

  • Knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review, and submission processes.
  • Ability to prepare and analyze technical and compliance-related documentation.
  • Familiarity with audit documentation and regulatory query management.
  • Document management and record-keeping skills.

Behavioral Skills Required

  • Strong attention to detail and accuracy.
  • Ability to work effectively under pressure and meet strict deadlines.
  • Team player with strong collaboration and coordination skills.
  • Proactive, adaptable, and willing to take initiative.
  • Professional communication and interpersonal skills.

Team Size to be Handled:

Individual contributor role, reporting to the Assistant Manager - RA.

Important Links:

Website:

LinkedIn:

Instagram:

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

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