Obtain fast new drug approvals through preparation of the required documentation and thorough follow-up with local health authorities.
Variations and renewals of already approved drugs.
Proactively identify regulatory trends and communicate potential impacts on company business.
Adhere strictly the timelines in Corporate SOP for submitting the registration information to Regulatory Information Management System (RIMS) Data Entry Team and verifying RIMS data.
Preparation of technical dossiers for price submission and tender application
Processing and reporting to Global Safety and Health Authorities all safety information received from market, post-authorisation studies, scientific literature and Health Authorities in accordance with national legislation and internal procedures.
Manage the product quality complaint process and handle product recalls.
Provide training to all employees and local agent(s) with regard to safety reporting, complaint management, and product recall.
Perform disposition of finished products for distribution or delegate the task to appropriate trained individuals.
Provide QA oversight of activities performed by distributor.
Act as the Management Representative for Ferring Malaysia to ensure that the processes needed for the local quality management system are established, implemented and maintained.
Responsible for Malaysia and Brunei markets.
Act as Local Safety Officer (LSO) for the Malaysia subsidiary.
Qualifications
Degree in Pharmacy
A registered pharmacist in Malaysia
Fluency in English and Bahasa Melayu
At least 5 years of Regulatory Affairs working experience
Direct experience of working with Regulatory Authorities
Knowledge of international guidelines and national legistration related to drug and medical device registration, and Pharmacovigilance
Capable of developing and implementing regulatory strategies.
