Job Description
Vacancy for Executive – Regulatory Affairs
At LAUGFS Life Sciences (Pvt) Ltd., a subsidiary of LAUGFS Holdings Ltd., we entered the pharmaceutical manufacturing industry with a state-of-the-art production facility in Koggala. Committed to saving lives, we proudly produce high-quality pharmaceuticals locally.
Key Responsibilities
- Prepare, compile and submit regulatory dossiers, product registration applications, licences, renewals and variations.
- Liaise with the National Medicines Regulatory Authority (NMRA), Ministry of Health (MOH), Food control Administration Unit, National Dangerous Drugs Control Board and other relevant regulatory authorities.
- Follow up on regulatory submissions and approval applications, and coordinate responses to queries raised by regulatory authorities.
- Work with Quality Assurance, Quality Control, Manufacturing and other relevant teams to obtain the technical information and supporting documents required for regulatory submissions.
- Review product dossiers, labels, packaging text and artwork to ensure regulatory compliance.
- Maintain accurate records of licences, certificates, submission trackers and approval statuses.
- Monitor changes in applicable Sri Lankan regulatory requirements and support ongoing regulatory compliance.
- Support regulatory inspections and audits, and prepare documentation requested by regulatory authorities.
Candidate Profile
- Bachelor’s degree in Pharmacy or Pharmaceutical Sciences.
- 1–2 years of experience in Regulatory Affairs, preferably in a pharmaceutical manufacturing environment.
- Knowledge of dossier preparation, regulatory submission procedures, product registration and licensing.
- Experience liaising with the NMRA and other relevant Sri Lankan regulatory authorities would be an advantage.
- Good written and verbal communication skills in English, with strong documentation skills.
- Proficiency in Microsoft Word and Excel.
- Strong attention to detail, with the ability to manage multiple tasks and meet deadlines.
- Ability to work effectively with cross-functional team.
If you are confident that you have the right skills, knowledge, attitude, and passion to grow with us, please forward your resume to hr.lifesciences@laugfs.lk within 10 days of this notice, including two non-related referees. Please mention the position applied for in the subject line.