Regulatory Manager

Lkcareers
Full-timeColombo, Sri LankaLKR 150,000 - 200,000/month

Key Responsibilities:

➢ Develop strategies to ensure that regulatory approvals are there to perform the activities of the

organization aligning the government regulations.

➢ Prepare, Evaluate and submit the formal documents applicable to regulatory authorities.

➢ Act as a coordinator between operations departments of the organization and the regulatory

authorities regarding order pipelines and product release to the market to ensure that the regulations

are met properly.

➢ Manage the with Quality Assurance including temperature monitoring, maintenance of quality

agreements, release of products for sale, product inspection (audits) and preparation and development

of Standard Operating Procedures.

➢ Develop and maintain professional relationships with all the regulatory agencies for smooth functions.

➢ Communicate with Principals by adhering to organizational polices and protocols to increase efficiency

and effective registration process.

➢ Maintain current knowledge of regulations applicable to the organization and update time to time and

monitor regulatory affairs and the effect changes on company operations.

Key Requirements:

➢ BSc in Pharmacy/ B. Pharm with minimum 5 years of working experience in a similar role.

➢ Hold the Certificate of Registration as a Pharmacist.

➢ Excellent communication, interpersonal and negotiation skills.

➢ Be Deadline-Oriented and possess Time Management skills.

➢ Thoroughly working with EPR / NAV environment.

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