Senior Specialist, RAQA

Under limited supervision responsible for the local implementation of regulatory and quality activities and strategies, obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of drugs, biologics and medical devices products.

Essential Duties & Responsibilities

• Strong experience in drugs and biologics
• Relevant experience in medical devices in Malaysia
• With direction, develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain awareness of regulatory requirements; identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• M...