Operations Manager – Tender & Regulatory Affairs

Job Details

  • Salary
  • Experience 7 Years Experience

Operations Manager – Tender & Regulatory Affairs

  • Sri Lanka

Job Purpose

The Operations Manager – Tender & Regulatory Affairs is responsible for providing strategic and operational leadership across tender management, regulatory affairs, and supply chain coordination to ensure compliant, timely, and sustainable business operations within a regulated healthcare environment. The role ensures effective engagement with government authorities, uninterrupted product availability, and adherence to all applicable regulatory and tender requirements.

Key Responsibilities

Tender Management

  • Lead and manage end-to-end tender participation, including planning, submission, coordination, and post-award activities

  • Act as the primary point of contact with government and institutional stakeholders (e.g., SPC, MOH/MSD, NMRA) related to tenders

  • Ensure tender submissions are accurate, compliant, competitive, and submitted on time

  • Coordinate cross-functional inputs (commercial, regulatory, supply chain, finance) to support tender success

Regulatory Affairs

  • Oversee regulatory compliance for products across their lifecycle, including NPD and ongoing registrations

  • Ensure timely and compliant product introductions in line with local healthcare regulations

  • Maintain effective working relationships with regulatory authorities and ensure all regulatory commitments are met

  • Monitor regulatory changes and assess business impact, recommending mitigation actions as required

Operations, Supply Chain & Logistics

  • Oversee end-to-end supply chain and logistics operations to ensure uninterrupted product availability

  • Coordinate forecasting, importation, release, and distribution activities in alignment with regulatory and tender commitments

  • Identify operational risks and implement controls to ensure continuity, quality, and compliance

Governance, Risk & Stakeholder Management

  • Ensure full adherence to internal policies, regulatory standards, and ethical practices

  • Identify and mitigate operational, regulatory, and reputational risks

  • Act as a key advisor to senior management on operational governance, compliance, and tender-related matters

  • Manage multiple workstreams and stakeholders across internal teams and external partners

Strategic Contribution

  • Contribute to sustainable business growth through effective operational planning, governance, and execution

  • Support continuous improvement initiatives across tender, regulatory, and supply chain processes

Qualifications & Experience

  • Bachelor’s degree in Pharmacy, Science, Engineering, Supply Chain, or Business Administration

  • Postgraduate or professional certification in Regulatory Affairs or Supply Chain is an advantage

  • 7–8 years of experience in healthcare, pharmaceuticals, medical devices, or other regulated industries

  • Proven hands-on experience with government authorities (SPC, MOH/MSD, NMRA)

  • Strong expertise in tender processes, regulatory compliance, and supply chain/logistics coordination

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