Regulatory Affairs Manager - Korea
US Fortune 500 market leader and manufacturer of consumer household and personal care
This position is responsible for product regulatory compliance in Korea. Will be an integral member of the company’s GS Organization and Asia business, setting the regulatory strategy, managing day-to-day operations and building our evolving regulatory capabilities across Korea. This will include developing and maintaining strong relationships with external regulatory experts, relevant governmental agencies and industry associations.
Key Responsibilities (in descending order of importance): % of Time
Regulatory Compliance - Ensure compliance for a broad product portfolio 30% including disinfectants, consumer packaged goods, OTC drugs and cosmetics, between others. a. Responsible for quality control in conformity with standards outlined for quality control b. Responsible for ensuring safety and standards for safety management c. Responsible for managing and supervising necessary tests, inspections,or examinations for the release of finished products
Reports and effectively translates technical information clearly & with appropriate 15% technical depth and provides balanced risk assessment leading to conclusions & regulatory recommendations.
Establish a robust network of consultants, industry experts and key stakeholders 15%
Conduct reviews of labels as well as marketing communications. 10%
Project support - Independently represent regulatory/compliance within project 15% teams, create recommendations for projects by working closely with Asian leaders & functions to move projects from discovery to launch; ensuring functional & technical excellence in work. Direct, plan & executes complex technical projects and difficult technical problems.
Assist with import process by maintaining import licenses and product 15% information files in coordination with other functions (PSO, Legal, Sales).
Years of experience in Regulatory Affairs function or related to Pharmaceutical/Health care and Personal care or CPG Company.
Experience interacting with regulatory agencies (e.g MFDS, MoE, etc). Working knowledge of relevant regulations, including K-REACH, Chemical Control Act, GMP, drug quality, cosmetics and others.
Skills and Abilities:
Strong interpersonal, communication and organizational skills.
Fluent in English and Korean.
Results oriented and process driven.
Experienced in determining technical approaches and applying them to achieve project objectives and strong/creative problem solver.
Strong knowledge of the regulated Asian industry, its products, packaging and manufacturing practices.
Ability to build and maintain effective relationships with both internal (PSO, Mkt, Sales) and external stakeholders in an effort to facilitate effective communication of business needs.
Proficiency at conveying information in a clear, focused and concise manner.
Experience in executing multiple projects simultaneously.
Strong negotiation and influence skills.
Attention to details within the context of driving for larger strategic results.
Ability to develop effective solutions to diverse and complex business problems .
Strong strategic thinking and execution abilities
Strong process orientation
Ability to focus on multiple issues at one time, ability to organize and direct diverse activities in a changing environment often under time pressure
Required Bachelor's Degree in Pharmacy (preferred) or Science/Chemistry.