Manager - Regulatory Affairs (Colombo)
About the Employer
Job Description
Vacancy for Manager Regulatory Affairs (Colombo)
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
- Manage and lead the Regulatory Affairs Department in addressing requirements from various regulatory authorities.
- Responsible for preparing, reviewing, and approving complete dossiers for regulatory authorities as per CTD guidelines.
- Authorized to handle inquiries from regulatory authorities related to company and product registrations.
- Submission of registration dossiers in Sri Lanka and other international markets.
- Ensure adherence to timelines for project submissions, including dossiers, query responses, variation reports, renewal procedures, and other regulatory applications.
- Coordinate and prepare for regulatory audits and quality management system setup.
- Review all technical documents to meet dossier preparation and registration requirements.
- Ensure compliance of company products with regulations in regions where they are distributed.
Candidate Profile
- A BSc in Pharmacy, Pharmacology, or a related discipline from a recognised university.
- A minimum of five years of work experience in the pharmaceutical manufacturing industry.
- Ability to travel to the site in Koggala as per company requirements.
- Excellent verbal and written communication skills, along with computer literacy.
Please forward your resume to [email protected] within 10 working days of this notice, with your supervisor’s approval, and mention the position applied for in the subject line.
