Regulatory Compliance Specialist

17 hours ago

Ahmedabad, Gujarat, India beBeeCompliance Full time ₹ 25,00,000 - ₹ 35,00,000
Regulatory Affairs Manager

This role focuses on ensuring the timely and compliant preparation of dossiers for regulatory submissions.

The Regulatory Affairs Manager will work closely with internal stakeholders to ensure that all submissions are in line with current regulatory guidelines and client expectations.

Key Responsibilities:

  • Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for ROW markets.
  • Coordinate with agents for regulatory submission and queries.
  • Track and manage timelines for submissions and approvals to ensure compliance with project milestones.
  • Monitor changes in regulatory guidelines and keep relevant stakeholders informed.
  • Ensure all submissions and regulatory strategies align with applicable national and international regulations.
  • Manage regulatory documentation for product variations, renewals, packaging/labelling updates, and post-approval changes.
  • Maintain and update regulatory databases and trackers.

Required Skills and Qualifications:

  • Excellent knowledge of regulatory affairs and guidelines.
  • Strong analytical and problem-solving skills.
  • Ability to work effectively in a team environment.
  • Strong communication and interpersonal skills.

Benefits:

  • Opportunity to work with a dynamic team.
  • Competitive salary and benefits package.
  • Ongoing training and development opportunities.

Others:

  • Ability to work in a fast-paced environment.
  • Flexibility to adapt to changing priorities.

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