Regulatory Affairs Specialist Operation, Growth Market

Key Responsibilities

Develop gold standard quality system processes for the regulatory function.
Lead internal and external audit activities.
Lead implementation of global/regional programs, and special projects.
Work with Regional/Country/Business Unit RA Team to identifies and lead process improvement activities.
Streamlining of various internal processes with regards to change management, labelling, reporting and tracking.
Lead the regulatory component of the management review process and RA functional review.
Develop training resources for the Regulatory Affairs function. Leads training of business partners and stakeholders on regulatory processes and requirements.
Leads operational activities, such as labelling, localisation, translations, systems, and tender requests.
Lead regulatory compliance activities, i.e. regional regulatory intelligence, regulation change impact assessment (RegMap) and execution activities.
Reporting and Tracking (new product, Change Notification, Renewals):
Maintenance & update of internal RA tool.
Preparation of RA reports for demand planner using RA tool.
Requirements

Minimum a Bachelor’s Degree in related fields such as Pharmacy, Pharmaceutical Science, Science, Biomedical Science, etc.
Minimum 3-years of working experience in regulatory affairs within medical device or pharmaceutical industry.
Able to work independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems.
Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges.
Critical thinker with good problem-solving skill and excellent communication skill.
Minimum intermediate level in MS Office skill and Windchill (good to have).