Regulatory Affairs & Quality Assurance Manager (2-Year Contract)

Job Description:At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.

Our Technical Operations division develops, manufactures and supplies high-quality products so our patients can live better lives. Creating and delivering life-changing products means getting it right first time is a shared responsibility, so our global manufacturing teams work closely together to ensure quality, accuracy and safety at all times. That means a culture of empowerment, where speaking up is valued, and growth and development are constant.

Ferring+You You will primarily be responsible for ensuring sound regulatory strategies for assigned products are formulated and executed to support the business goals of the Malaysia and Brunei.

Your day at Ferring

• 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.

Behind our innovation…There’s you

• 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
• Experience with ASEAN regulations would be ideal.
• Capable of developing and implementing regulatory strategies.
• Strong communication skills
• Competency in cross-functional collaborations.
• 2 years contract.

Behind our purpose… There’s youIf our mission and your vision are aligned, please apply!We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.
Location:Ferring Malaysia