Regulatory Affairs Manager(Immunology), Korea

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

Qualifications

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.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html