Senior Regulatory Affairs Specialist

Job Description

Position: Sr. RA Specialist
Reports to: Regulatory Affairs Manager
Location: Seoul, South Korea

PRIMARY FUNCTION/OBJECTIVE

To manage the preparation of regulatory submissions of company products in order to obtain the necessary regulatory approvals and to provide regulatory input on regulatory matters to company personnel.

CORE JOB RESPONSIBILITIES

• Developing RA strategies - assess timeline and lead development of regulatory strategy for new assets and line extensions based on the regulatory requirements as well as reflecting cross-functional team considerations. Support RA manager in developing regulatory strategies.
• Identifying and resolving regulatory issues and challenges that may arise during the product development, registration, or post-market phases
• Collaborating with cross-functional teams, such as R&D, Quality Assurance, and Marketing, to gather necessary information and support regulatory affairs activities.
• Participating in problem-solving discussions and providing input on regulatory matters to support decision-making processes.
• Set up timelines on managing variations in accordance with strategy
• Reviewing and evaluating product labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
• Conducting research on regulatory requirements and staying updated on changes in regulations and guidelines as Subject Matter Experts
• Evaluation of impact, implementation plan on the marketed products (hurdle, current situation) risk management, problem solving
• Product discontinuation/withdrawal/Marketing Authorization Transfer /co-promotion/co-marketing strategy reflecting feedback from internal stakeholders and global strategy
• Conducting thorough reviews of contract terms and conditions to identify any regulatory implications or requirements that need to be addressed.

Qualifications

PREFERRED QUALIFICATIONS

• Education: Bachelors or equivalent degree in appropriate discipline
• More than 5 years’ experience in a regulatory position in pharma industry
• Experience in Oncology or Orphan Drug Designation preferred
• Proficiency in both spoken and written English
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
• Good interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, and creativity. Demonstrated proactive and positive team player.
• Drives continuous improvement and simplicity in process and approach and enhances agility.

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. 

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