Global Regulatory Affairs Expert

4 days ago

Noida, Uttar Pradesh, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000
Regulatory Specialist

We are seeking a highly skilled Regulatory Specialist to join our team. The ideal candidate will have extensive experience in managing regulatory systems and ensuring compliance with business goals and regulations.

  • This role requires strong analytical skills, attention to detail, and the ability to communicate complex information effectively.

The successful candidate will be responsible for:

  1. Managing product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value.
  2. Collaborating with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards.
  3. Facilitating workshops, requirement-gathering sessions, and backlog grooming using Confluence for documentation and collaboration.

The ideal candidate will possess:

  • Strong knowledge of pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards.
  • Experience in managing change control and validation activities for regulated systems.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

Benefits include:

  • A dynamic and supportive work environment.
  • Ongoing training and development opportunities.
  • A competitive compensation package.

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