Senior Regulatory Affairs Specialist

About the role

The Senior Regulatory Affairs Specialist will lead the preparation of regulatory submissions for AbbVie’s products in South Korea, ensuring timely approvals and compliance. This role collaborates closely with cross‑functional teams to provide regulatory guidance throughout product development, registration, and post‑market phases.

Key responsibilities

• Develop and assess regulatory strategies for new assets and line extensions, aligning timelines with cross‑functional considerations.
• Identify and resolve regulatory issues during development, registration, and post‑market activities.
• Collaborate with R&D, Quality Assurance, Marketing, and other teams to gather information and support regulatory affairs tasks.
• Review product labeling, packaging, and promotional materials for regulatory compliance.
• Conduct research on evolving regulatory requirements and act as a subject‑matter expert.
• Manage product variations, discontinuations, withdrawals, and marketing‑authorization transfers in line with global strategy.

Required profile

• Bachelor’s degree or equivalent in a relevant discipline.
• More than 5 years of regulatory experience in the pharmaceutical industry, preferably in oncology or orphan drug designation.
• Proficiency in spoken and written English.
• Strong analytical, critical‑thinking, and problem‑solving abilities.
• Excellent interpersonal and communication skills, with a proactive team‑player attitude.