Regulatory Affairs Manager (Biotech)

Location: Beijing, China

Company

hirify.global is a biotechnology company developing and commercializing medicinal products and related healthcare solutions.

What you will do

• Apply for, obtain, and maintain regulatory approvals across product life-cycle activities, including CTNs, MAAs, renewals, and variations.
• Prepare timely regulatory submissions that meet corporate standards and local regulatory requirements.
• Develop and implement product regulatory strategies, processes, and activity plans under manager guidance.
• Interact and negotiate with regulatory authorities to optimize approvals.
• Support local regulatory projects, Therapeutic Areas, and Scientific Affairs activities.
• Monitor legislation, regulatory guidance, and regulatory intelligence; oversee external vendors or contractors where applicable.

Requirements

• Doctorate degree; or a master’s degree with 3 years of directly related experience; or a bachelor’s degree with 5 years of directly related experience; or an associate’s degree with 10 years of directly related experience.
• Expertise in national, mutual recognition, centralized, and biotechnology product regulations, as well as medical device registration.
• Knowledge of medicinal product legislation, registration procedures, regulatory policies, procedures, and SOPs.
• Understanding of drug development and experience managing regulatory processes.
• Strong communication, teamwork, negotiation, supervisory, and issue-prevention skills.

Nice to have

• Experience in multinational companies.
• Experience with biologics.
• Experience in medical device registration.
• Multilingual abilities.

Culture & Benefits

• Full-time employment.
• Opportunity to work across national, European, US, and biotechnology regulatory frameworks.
• Collaboration with Therapeutic Areas, Scientific Affairs, International Regulatory Affairs, regulatory authorities, and external vendors.