Regulatory Affairs Manager (Pharmaceuticals)

Location: Taipei, Taiwan

Company

hirify.global develops medicines and solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Manage registrations for new products, variations, medical devices, and early pipeline products.
• Prepare regulatory submissions, registration plans, status reports, and responses to deficiency letters and authority data requests.
• Liaise with government agencies to facilitate product evaluations and approvals.
• Update and review product labeling and information for compliance with regulations and codes.
• Design regulatory affairs strategies, lead cross-functional meetings, and communicate regulatory and business impacts to management.
• Lead regulatory projects, manage team performance, and improve regulatory processes and standard operating procedures.

Requirements

• University degree in Pharmacy, Pharmacology, Biology, or a related discipline.
• About 8 years of experience with in-depth knowledge of Taiwan regulatory requirements in the medical device or pharmaceutical industry.
• Strong communication, coordination, interpersonal, and computer communication skills.
• Ability to communicate strategic and tactical issues to management.
• Fluent English, both spoken and written.

Nice to have

• Experience with new drug applications for new chemical entities and clinical drug development.

Culture & Benefits

• Work in a regulated pharmaceutical and medical device environment focused on innovation and compliance.
• Collaborate with local regulatory authorities, corporate regulatory affairs, business units, and senior management.
• Equal opportunity employment with a commitment to integrity, innovation, and community impact.