Regulatory Affairs Manager(Immunology), Korea

PRIMARY OBJECTIVE:

• To manage the preparation of regulatory submissions of company products in order to obtain necessary regulatory approvals
• To provide regulatory input on regulatory matters to company personnel.
• This position will report to the RA Director with people management scope.

CORE JOB RESPONSIBILITIES:

• Develop registration strategies and implement regulatory plan in accordance with strategic company objectives.
• Manage registration of new/line extension products, variations to marketed products to ensure regulatory approvals are achieved in accordance with Company objectives.
• Oversee regulatory affairs activities within the team, including regulatory submissions, approvals, and compliance.
• Manage safety update reports, certified product details and import permits
• Maintain contact with governmental officials of Korea MFDS to facilitate evaluation processes.
• Liaise with operations department and others to maintain product changes and ensure these comply with regulations.
• Review and assess product labeling, packaging, and promotional materials for compliance with relevant regulations and codes.  
• Collaborating with cross-functional teams to identify and address regulatory compliance gaps and develop corrective actions.
• Analyzing and interpreting complex regulatory requirements and guidelines to determine their applicability to the organization's products and operations.
• Proactively identifying potential regulatory risks and proposing mitigation strategies to ensure compliance and minimize business impact.
• Provide support for marketing plans and launch teams
• Maintain good knowledge of the relevant Regulations & Code.
• Bridge for translating regulatory strategies and goals into launch plans that drive the business
• Manage performance of the Therapeutic Area
• Coach and develop team members to achieve their best target
• Shape the culture of the team
• Serve as a Back-up to the RA Director: Act as the deputy and take on the responsibilities of the RA Director in their absence.

EDUCATION/QUALIFICATIONS/EXPERIENCE:

• University degree in appropriate discipline
• More than 10 year experience in a regulatory position in the pharma industry with proven track records in driving new drug project, new launch, new 
• Experience in immunology will be preferred
• Experience in people management is a great plus
• Must be proficient in both spoken and written English.

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