Senior Technology Regulatory Compliance Analyst - Technology IT

Regulatory Compliance Oversight:

• Lead compliance efforts for technology functions to ensure adherence to global regulatory standards, including FDA 21 CFR Part 11, GAMP 5, ICH GCP, and EMA guidelines.

• Develop, implement, and maintain compliance frameworks for Enterprise IT, Cloud Operations, and R&D.

• Provide expert advice on regulatory requirements during the development and deployment of software products.

• Ensure software products meet global regulatory requirements applicable to the life sciences industry.

Audit and Risk Management:

• Plan and lead internal audits of IT systems and processes to assess compliance readiness.

• Support external audits and inspections by regulatory authorities and customers.

• Conduct risk assessments, identify potential compliance gaps, and oversee the implementation of mitigation strategies.

Policy and Documentation Management:

• Develop, review, and update policies, SOPs, and other documentation to align with regulatory requirements.

• Ensure validation and verification processes for IT systems and software are adequately documented and maintained.

Collaboration and Cross-Functional Engagement:

• Collaborate with Enterprise IT, Cloud Operations, and R&D teams to embed compliance into system design, software development, and operations.

• Act as a liaison with external stakeholders, including auditors and regulatory bodies, to address compliance-related queries.

Training and Mentorship:

• Design and deliver training programs on regulatory compliance requirements for technology teams in India.

• Mentor and guide junior analysts to ensure consistent application of compliance principles.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance compliance processes and frameworks across technology functions.

• Stay updated on emerging trends and regulatory changes impacting the life sciences and software development industries.

• bachelors degree in Information Technology, Computer Science, Regulatory Affairs, or a related field.

• Advanced degree or certifications (eg, RAC, CRCP, or equivalent) preferred.

• 5-10 years of experience in IT regulatory compliance, particularly in life sciences or software development.

• Strong experience with global regulatory frameworks, including FDA 21 CFR Part 11, GAMP 5, and ICH GCP.

• Comprehensive understanding of IT systems, cloud operations, and software development lifecycle (SDLC).

• Proven ability to manage audits and regulatory inspections with strong problem-solving skills.

• Excellent project management, communication, and leadership abilities.

• Experience in working with geographically dispersed teams and global stakeholders.

• Familiarity with Agile and DevOps methodologies.

• Experience with compliance in cloud-based environments and data security standards.

• Medical Insurance, Group Accidental Coverage/Insurance, Group Term Life Insurance

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