Regulatory Affairs Manager
REGULATORY AFFAIRS MANAGER
This company is a young and innovation driven pharmaceutical company that engages in the discovery, research and development, validation and commercialization of unique natural compounds with therapeutic properties in the nutritional, cosmeceutical, animal health and pharmaceutical markets. They are focused on innovative strategies that can generate first-in-class compounds representing real advancements in scientific and medical thinking. In addition, they are amongst the first to be granted BioNexus status by the Malaysian Biotech Corporation.
Due to the dynamic growth of their business activities in Europe and Asia Pacific,
they are seeking high caliber individuals to join them. This position will be based at their Global Operational Headquarters at Plaza Mont Kiara, Kuala Lumpur,
Malaysia.
Responsibilities:
• To assist the Head of Department for overall regulatory application and
registration processes.
• To provide regulatory and legislation guidance, reviews of relevant authorities and sources.
• To carry out literature research in creating creative solutions for regulatory challenges in registration process.
• To gather and maintain relevant documentations internally and design regulatory documents in timely manner for product registration.
• To submit and follow up on product regulatory applications to relevant authorities and business partners.
• To provide expert interface with internal and external parties for regulatory activities.
• To develop and maintain policies, procedures and records related to
regulatory affair to ensure compliance with Quality Management Systems (QMS.
Requirements:
• Candidates must possess a Bachelor’s degree in Life Science/Pharmacy or its equivalent.
• At least 6 to 8 years of working experience in regulatory affairs in medical device or pharmaceutical industry with preferably 3 years in a managerial or supervisory role.
• Possess comprehensive knowledge on the medical devices and other related regulatory requirements for various countries.
• Good interpersonal, technical and communication skills with a high level
of proficiency in verbal and written English.
• Innovative, resourceful and a team player with the ability to work independently in a dynamic & challenging environment.
Applicants are invited to e-mail their application to ishvinder.kaur@robertwalters.com.my or call 603-23808744 quoting job reference number 502000.