Pharma/Healthcare SME

2 days ago

Bengaluru, Karnataka, India L&T Technology Services Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Job Summary:

We are looking for a highly skilled Pharmaceutical Subject Matter Expert (SME) to provide deep industry knowledge and strategic guidance in pharmaceutical operations, technology, compliance, and digital transformation. The SME will work closely with cross-functional teams, helping drive innovation, regulatory adherence, and efficiency across drug development, manufacturing, supply chain, and commercial operations.

Key Responsibilities:

  • Industry Expertise & Strategic Advisory:
  • Provide in-depth knowledge of pharmaceutical industry trends, challenges, and best practices across R&D, clinical trials, regulatory, manufacturing, and commercialization.
  • Advise clients on digital transformation initiatives, including AI/ML, RPA, blockchain, and IoT in pharma applications.
  • Stay updated on evolving regulatory frameworks (FDA, EMA, HIPAA, GDPR, GAMP 5) and guide compliance strategies.
  • Regulatory & Compliance Advisory:
  • Ensure GxP compliance across pharmaceutical processes and IT implementations.
  • Support validation and qualification of systems (LIMS, CTMS, MES, QMS, ERP) to meet industry standards.
  • Guide organizations through FDA audits, inspections, and regulatory submissions.
  • Technology & Digital Transformation:
  • Collaborate with IT teams to implement pharma-specific technology solutions, including cloud platforms, AI-driven drug discovery, and data analytics.
  • Assist in the integration of ERP, CRM, CTMS, and supply chain solutions to enhance operational efficiency.
  • Develop strategies for data integrity, cybersecurity, and governance in pharmaceutical environments.
  • Stakeholder Engagement & Training:
  • Act as a trusted advisor to business leaders, R&D teams, regulatory affairs, and IT professionals.
  • Conduct workshops, training sessions, and knowledge-sharing initiatives to ensure alignment with best practices.
  • Work closely with vendors, technology partners, and regulatory bodies to shape industry-compliant solutions.

Required Skills & Experience:

  • 15 Years of Experience in the pharmaceutical industry with expertise in R&D, clinical trials, manufacturing, regulatory compliance, or supply chain.
  • Strong understanding of GMP, GCP, GDP, and GAMP 5 principles.
  • Experience with pharma technology ecosystems, including SAP, Oracle, Veeva, Salesforce, LIMS, CTMS, MES, QMS.
  • Familiarity with emerging technologies like AI/ML, RPA, blockchain, IoT, and cloud computing in pharma applications.
  • Excellent communication and stakeholder management skills to bridge business and IT teams.

Preferred Qualifications:

  • Bachelor's or Master's degree in Pharmacy, Life Sciences, Bioinformatics, or a related field.
  • Certifications in Regulatory Compliance, GAMP, Six Sigma, or pharma technology platforms.

Experience working with global pharma companies and navigating international regulatory landscapes

Thanks & Regards

HR Team

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