Regulatory Affairs Manager – NMRA, ROP & CEA

Job Details

  • Salary
  • Experience 6 Years Experience

Regulatory Affairs Manager – NMRA, ROP & CEA

  • Sri Lanka

Job Summary

We are looking for an experienced and results-oriented Regulatory Affairs Manager – NMRA, ROP & CEA to manage regulatory affairs, statutory approvals, product registrations, licensing, and regulatory compliance in Sri Lanka.

The ideal candidate must have hands-on experience working with the National Medicines Regulatory Authority (NMRA), Registrar of Pesticides (ROP), and Central Environmental Authority (CEA). The candidate should be capable of independently managing regulatory submissions, obtaining approvals, coordinating registrations and renewals, handling inspections and audits, and maintaining compliance with applicable regulatory requirements.

Key Responsibilities

  • Manage regulatory affairs and ensure compliance with applicable Sri Lankan regulatory requirements.

  • Coordinate with the National Medicines Regulatory Authority (NMRA), Registrar of Pesticides (ROP), and Central Environmental Authority (CEA) to obtain necessary approvals, registrations, licences, and permits.

  • Prepare, submit, monitor, and follow up on regulatory applications, product registrations, renewals, and other statutory documentation.

  • Ensure timely renewal of registrations, licences, permits, and other regulatory approvals.

  • Handle regulatory inspections, audits, and compliance assessments, ensuring all required documentation and records are maintained.

  • Monitor changes in regulatory requirements, policies, guidelines, and procedures, and advise relevant stakeholders accordingly.

  • Maintain accurate regulatory records, documentation, and compliance reports.

  • Liaise with relevant government authorities and internal departments to resolve regulatory issues and facilitate approvals.

  • Provide guidance on regulatory requirements relating to product registrations, licensing, environmental compliance, and statutory obligations.

  • Build and maintain strong professional relationships with regulatory authorities and other relevant stakeholders.

  • Identify potential regulatory risks and implement appropriate measures to ensure ongoing compliance.

  • Independently manage regulatory matters and ensure regulatory activities are completed accurately and within the required timelines.

Preferred Candidate Profile

We are looking for a candidate with proven experience in handling regulatory matters with the following key regulatory bodies in Sri Lanka:

  • NMRA (National Medicines Regulatory Authority) – Mandatory

  • ROP (Registrar of Pesticides) – Mandatory

  • CEA (Central Environmental Authority)

The ideal candidate should have hands-on experience in obtaining approvals, managing registrations and renewals, handling inspections and audits, maintaining regulatory compliance, and building strong relationships with these authorities.

Experience Requirements

  • Minimum 5 years of experience in Regulatory Affairs.

  • Mandatory hands-on experience working with NMRA, ROP, and CEA.

  • Experience in FMCG, pharmaceutical, chemical, consumer goods, or manufacturing industries is preferred.

  • Experience in regulatory submissions, licensing, product registrations, environmental compliance, and statutory audits.

  • Proven ability to independently manage regulatory approvals, registrations, renewals, and compliance activities.

Required Skills & Competencies

  • Strong knowledge of Sri Lankan regulatory requirements and statutory compliance.

  • Sound understanding of NMRA, ROP, and CEA regulations, processes, and approval procedures.

  • Excellent stakeholder management and government liaison skills.

  • Strong communication, negotiation, and problem-solving abilities.

  • Good documentation, coordination, and organisational skills.

  • Ability to manage multiple regulatory matters independently and meet deadlines.

  • Strong attention to detail and commitment to maintaining regulatory compliance.

Ideal Candidate

The ideal candidate will be a proactive regulatory affairs professional with strong technical knowledge of Sri Lankan regulatory processes, established experience dealing with NMRA, ROP, and CEA, and the ability to independently manage regulatory approvals, registrations, renewals, inspections, and compliance requirements.

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