Assistant Manager – Regulatory Affairs

Job Details

  • Salary
  • Experience 5 Years Experience

Assistant Manager – Regulatory Affairs

  • Sri Lanka

Job Purpose

The Assistant Manager – Regulatory Affairs is responsible for ensuring regulatory compliance across the company’s healthcare product portfolio, which includes surgical, pharmaceutical, FMCG, cosmeceutical, and nutraceutical categories. This role oversees regulatory submissions, certifications, factory compliance, and SOP governance, while effectively managing resources and building strong relationships with regulatory authorities and industry partners.

Key Responsibilities

Regulatory Submissions & Compliance

  • Prepare, compile, and submit high-quality regulatory dossiers and documentation to local and international authorities for product registrations and certifications.

  • Liaise with regulatory bodies to monitor application status and respond promptly to queries, clarifications, or deficiencies.

  • Maintain an organized tracking system for submissions, approvals, renewals, and expiry timelines.

Factory Compliance & GMP Assurance

  • Coordinate internal and external audits to obtain and maintain GMP certifications for manufacturing facilities.

  • Support validation and qualification activities for product and process approvals.

  • Assist in training factory teams on regulatory updates and SOP enhancements.

Documentation & SOP Management

  • Support documentation control activities, including version updates, revision tracking, and process validation.

  • Assist in updating SOPs to reflect regulatory changes, audit findings, and industry best practices.

Stakeholder Engagement & Networking

  • Develop and maintain strong professional relationships with regulatory authorities, certification bodies, trade associations, and healthcare institutions.

  • Represent the company at regulatory meetings, industry forums, and inspections.

  • Gather and analyze regulatory intelligence to anticipate trends and plan proactive strategies.

Strategic Support

  • Contribute to the company’s five-year strategic plan by ensuring timely regulatory approvals and product registrations in line with business goals.

Required Qualifications & Experience

  • Professional certification, diploma, or degree in Regulatory Affairs or Quality Management (preferred).

  • Minimum 4–5 years of hands-on experience in regulatory roles within healthcare or pharmaceutical manufacturing.

  • Strong knowledge of NMRA processes is mandatory.

  • Deep understanding of regulatory requirements across surgical, pharmaceutical, wellness, and related product categories.

  • Strong project management and organizational skills.

  • High attention to detail, especially in documentation and legal submissions.

  • Excellent communication and negotiation skills with internal teams and external authorities.

  • Ability to work independently and collaboratively in cross-functional environments.

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