Summary
• This role provides regulatory support for new product registration and post market support. The product portfolio consists of therapeutic products of small molecules and biologics as well as medical devices. Responsibilities include preparing and implementing regulatory plans, supporting regulation changes and completion of regulatory deliverables. This includes managing regulatory registrations with the global teams, impact assessments, new registrations, post-approval changes, and renewal, liaising with internal and external stakeholders.
• Must be a team player who can work independently and able to take initiatives. Well versed in pharmaceuticals and biologics regulatory landscape with at least 4 years of regulatory experience.
Essential Duties and Responsibilities
• Lead in the development and implementation of the regulatory strategy for therapeutic products and medical devices.
• Compile, prepare and submit new product registration, variations, change notifications, renewals and ensure approvals in a timely manner.
• Prepare and ensure product labelling is in line with country regulations.
• Learn, drive and manage various databases and reports ensuring information is accurate and up to date. Maintain regulatory files in a format consistent with requirements.
• Conducts regulatory monitoring of approved products by maintaining and ensuring files are current, comply with the local regulations, evaluates the effects of an amendment or change notification and follow up with the appropriate regulatory actions.
• Maintain proper documentation of all registered records in company database.
• Work collaboratively with cross-functional team to ensure regulatory compliance and market continuity.
• Serve as key contact person for regulatory affairs and provide regulatory assessment to the cross-functional team.
• Communicate and, if necessary, negotiate with country Regulatory Agency to support key submissions/projects.
• Manage change controls and create strategies to support the execution and implementation of changes required for the project.
• Able to develop and implement appropriate regulatory strategies for the country to ensure business optimization.
• Stay informed on regulatory changes and work towards the implementation of the new policy.
• Participate and maintain working relationships to relevant functional and business unit's team members.
• Identify opportunities for process improvement in product registration.
Education and/or Experience
• Bachelor’s degree in pharmacy, biochemistry, bioscience, chemistry or science degree
• Experience working in RA with new registration, license extensions, variations and renewals in therapeutic products and medical devices
• Minimum 4 years of relevant experience in pharmaceutical and biologic or medical device industry
