Regulatory Affairs and Quality Assurance Manager

Job Description
Pharma.MT is a young dynamic, results focus pharma importer and distributor. As we seek to grow the company further, the company is looking to recruit a Full-Time Regulatory Affairs and Quality Assurance Manager to work as part of their team.

Job Role: 
The ideal candidate shall be responsible for all Regulatory and Quality Assurance aspects within the company. This includes registration of new products, maintaining product licenses, and managing the maintenance of the Quality System.

The person shall also be responsible for:

• Devising strategies for registration of new products and advising stakeholders in advance of costs and efforts involved
• Registering new products in a timely manner
• Obtaining all deliverables from suppliers/ clients as may be required and liaising with the respective Regulatory body for successful registration.
• Acting as Subject Matter Expert on all Regulatory Related Aspects
• Informing and getting authorization from Competent bodes for importing Non-Pharma Products and any queries from any authority or advertising monitoring bodies regarding promotional materials in a timely manner.
• Provide and document training as necessary to ensure the qualification of personnel.
• Fulfill responsibilities personally and be continuously contactable.
• Audit and ensure the qualification of suppliers, customers, and outsourced companies
• Implement a self-inspection programme covering all aspects of GDP
• Storing and securing all documentation and records
• Highlighting and creating awareness of counterfeit or falsified products throughout the team
• Quality control of Shipments and ensure correct storage.

The Selected candidate shall have:

• A Pharmacy degree level of education and registered as a responsible person with the Malta Medicines Authority
• Knowledge of marketing and communication media
• Creativity and a flair to be innovative
• Verbal and written communication skills
• Organisational and interpersonal skills. 

Pharma.MT Ltd:
Pharma.MT is a young dynamic company yet we share many years of valuable experience. We are highly motivated and hard-working and as a result, have grown dramatically in the past few years and succeeded in securing various well known international brands. Our aim is to become the leading distributor for health care and allied products in Malta and Gozo. Pharma.MT Ltd has an excellent long-standing relationship with the medical community and a partnership approach with community pharmacies. We value our staff and invest heavily in employing and training the right people. Our team includes marketing and sales specialists, sales representatives, medical representatives, in-store promoters and merchandisers. Who are closely supported by graphic designers, regulatory affairs (qualified pharmacists including in house Qualified person and responsible persons), logistics and our finance and business development department.