Regulatory Compliance Specialist

1 day ago

Belgaum, Karnataka, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000
Job Title: Regulatory Compliance Specialist

We are seeking a highly skilled Regulatory Compliance Specialist to play a vital role in ensuring our organization's systems and processes comply with relevant regulatory standards.

About the Role:

  • This is an exciting opportunity for a compliance professional to work closely with cross-functional teams to identify, assess, and mitigate risks associated with non-compliance.
  • You will be responsible for developing and implementing compliance programs, policies, and procedures to ensure alignment with regulatory requirements.
  • Your expertise in GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 will be essential in guiding the development of compliant systems and processes.

Key Responsibilities:

  1. Conduct thorough risk assessments to identify potential compliance gaps and develop mitigation strategies.
  2. Collaborate with stakeholders to implement compliance programs, including training, audits, and documentation reviews.
  3. Stay up-to-date with changing regulatory requirements and provide guidance on compliance implications.
  4. Develop and maintain compliance-related policies, procedures, and guidelines.

Requirements:

  • 4-7 years of experience in compliance and validation roles.
  • Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
  • System validation aligned with regulatory standards.
  • Well-versed with System Life Cycle.
  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.

Educational Requirements:

Bachelor's degree or equivalent experience.

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