Regulatory Affairs Manager

📋 Description

• Independently manage registration of new products and variations to marketed products (including
• Ensure new product registrations including BSE submissions and approval maintenance is conducted in
• Coordinate responses to deficiency letters and other requests for data from regulatory authorities
• Liaise with officials of government agencies to facilitate evaluation processes and respond to
• Update product labeling in a timely manner based on the update of the product labeling from
• Review labeling and product information to ensure compliance with relevant regulations and codes.

🎯 Requirements

• University degree in Pharmacy, Pharmacology, Biology or related disciplines
• About 8 years’ experience and in-depth knowledge of Taiwan Regulatory in Medical Device or
• Strong communications and coordination skills
• Proficiency in communicating strategic and tactical issues to management
• Proven interpersonal skills
• Excellent oral, written and good computer communication skills, including fluent English.

🎁 Benefits

• Equal Opportunity Employer
• Commitment to operating with integrity, driving innovation, transforming lives and serving our