17933 RA Manager
・Achievement of timely submissions and approvals.
・Accurate projections for regulatory approvals.
・Maintain regulatory compliance.
・Lead sub-divided team within department (if required)
・Lead cross-functional team within company (if required)
・Update RA head on approval projections in a timely manner.
・Act as the primary interface with internal stakeholders.
・Contribute in business development from the aspects of regulatory.
・Conduct preparation of regulatory submissions and responses to regulator.
・Handle regulatory inspections and preparations as required.
・Capture any regulatory changes and communicate the impact with internal stakeholders
・Complete all deliverables on time to fulfill MAH representative responsibilities in case that
he/she is in charge.
・BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medical or law.
・Advanced degree or additional professional training is preferred.
・A license of Pharmacist is desirable.
・8+ year experience in Regulatory Affairs or equivalent.
・Successful submissions for medical devices, quasi drugs or RX.
・Demonstrated communication skill in international business environment.
・Regulatory experience with pharmaceuticals is desirable
・Leadership skill demonstrated in business setting.
・Hands-on submission experience.
・Analytical and problem solving skills.
・Ability to read, analyze and interpret regulations, technical documents and business numbers.
・Good oral and written communication skill demonstrated in medical business setting.
・Business English in writing and verbal.