Senior Regulatory Affairs Manager

2 weeks ago

Nellore, Andhra Pradesh, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 13,80,000
Regulatory Compliance Specialist

The key objective of this role is to maintain regulatory compliance and ensure adherence to international guidelines and country-specific requirements.

  • Key Responsibilities:
  • Screen, analyze, and prioritize regulatory documents for timely submission;
  • Draft, compile, and review product dossiers in compliance with customer and regulatory requirements;
  • Manage legalization or apostillation of registration documents;
  • 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;
  • 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;
  • 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;
  • Benefits:
  • Contribute to maintaining high-quality regulatory standards;
  • Opportunity to develop expertise in regulatory affairs and compliance;
  • Promote a culture of compliance within the organization;

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