Regulatory Affairs Sr Mgr

Location: Beijing, China

Company

hirify.global manages regulatory activities for a portfolio that includes biotechnology products, medicinal products, and medical devices.

What you will do

• Apply for, obtain, and maintain regulatory approvals, including CTNs, MAAs, renewals, variations, and other lifecycle activities.
• Prepare timely regulatory submissions that comply with corporate standards and local requirements.
• Develop and implement product regulatory strategies, processes, and activity plans in line with national legislation.
• Lead interactions and negotiations with regulatory authorities to facilitate approvals.
• Support Therapeutic Areas, Scientific Affairs, local regulatory initiatives, and International Regulatory Affairs with regulatory intelligence.
• Oversee external vendors and contractors where applicable.

Requirements

• Doctorate degree and at least 5 years of directly related experience, or a master’s degree and at least 8 years, or a bachelor’s degree and at least 12 years.
• Strong expertise in national, MRP, and centralized regulatory procedures for biotechnology products and medical devices.
• Experience interacting with regulatory authorities and managing complex regulatory projects.
• In-depth knowledge of national legislation, medicinal product regulations, policies, procedures, and SOPs.
• Understanding of European and US regulatory pathways, including MAAs, variations, extensions, and renewals.
• Strong leadership, communication, negotiation, stakeholder management, teamwork, and issue-mitigation skills.

Nice to have

• Experience working in multinational corporations.
• Experience with biologics, oncology, or medical device registration.
• Proficiency in multiple languages.

Culture & Benefits

• Full-time employment.
• Collaboration with Therapeutic Areas, Scientific Affairs, International Regulatory Affairs, regulatory authorities, vendors, and contractors.