Regulatory Affairs Professional

4 days ago


Bengaluru, Karnataka, India beBeeRegulatory Full time
Regulatory Affairs Professional

This role is responsible for leading the development and execution of regulatory strategies and documents in support of clinical trials and product registration.

  • Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with relevant regulations and guidelines.

  • Prepare and review regulatory documents, including clinical trial protocols, informed consent forms, and regulatory submissions.

  • Collaborate with cross-functional teams, including clinical operations, medical writing, and regulatory affairs, to ensure timely and accurate delivery of regulatory documents.

  • Maintain knowledge of regulatory requirements and guidelines, including ICH, GCP, and FDA regulations.

  • Provide regulatory guidance and support to colleagues and external partners as needed.

Required Skills and Qualifications
  • Bachelor's degree in a scientific or health-related field
  • Proven experience in regulatory affairs, including clinical trial management and document preparation
  • Strong understanding of regulatory requirements and guidelines
  • Excellent communication and project management skills
  • Ability to work effectively in a team environment
Benefits
  • Ongoing training and professional development opportunities
  • Collaborative and dynamic work environment
  • Competitive compensation and benefits package
Others
  • Maintenance of current knowledge of regulatory requirements and guidelines
  • Ability to adapt to changing priorities and deadlines


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