JOB DESCRIPTION FOR REGULATORY AFFAIRS MANAGER –SOUTH KOREA
1. GENERAL REQUIREMENTS
Global Regulatory Partners (GRP) is seeking an experienced Regulatory Affairs Manager to support regulatory activities for pharmaceutical products, cosmetics, and quasi-drug products in South Korea.
The successful candidate will serve as the primary regulatory contact for Korean regulatory matters and will be responsible for planning and executing regulatory strategies, preparing and submitting regulatory applications, maintaining product registrations, monitoring regulatory changes, and ensuring compliance with applicable Korean regulations.
The position requires extensive interaction with the Ministry of Food and Drug Safety (MFDS), clients, partners, and internal cross-functional teams.
2. RESPONSIBILITIES
Pharmaceutical Regulatory Affairs
- Develop and execute regulatory strategies for pharmaceutical products in South Korea.
- Prepare, review, compile, and submit regulatory dossiers to MFDS.
- Manage new registrations, amendments, variations, renewals, and lifecycle maintenance activities.
- Coordinate responses to health authority questions, deficiency letters, and regulatory requests.
- Support regulatory activities related to product launches.
- Review labeling, product information, packaging materials, and promotional materials for regulatory compliance.
- Provide regulatory guidance to internal teams and clients.
Cosmetics Regulatory Affairs
- Support cosmetic product notifications and registrations in accordance with Korean regulations.
- Review product formulations, claims, artwork, labeling, and package inserts.
- Monitor regulatory changes affecting cosmetic products.
- Provide regulatory recommendations for product development and commercialization.
Quasi-Drug Regulatory Affairs
- Support registration and maintenance of quasi-drug products.
- Review labeling, claims, and marketing materials.
- Ensure compliance with Korean quasi-drug regulations.
- Liaise with MFDS regarding approvals and regulatory inquiries.
Regulatory Intelligence and Compliance
- Monitor changes to Korean pharmaceutical, cosmetic, and quasi-drug regulations.
- Assess the impact of emerging regulatory requirements on clients and products.
- Maintain regulatory compliance throughout the product lifecycle.
- Support audit and inspection readiness activities.
- Assist with development and maintenance of regulatory procedures, work instructions, and templates.
- Maintain submission trackers and regulatory databases.
Cross-Functional Collaboration
Work closely with:
- Quality Assurance
- Pharmacovigilance
- Medical Affairs
- Clinical Operations
- Supply Chain
- Manufacturing
- Business Development
- Project Management
to ensure regulatory requirements are incorporated into business activities and product development plans.
Importation and Local Representation Support
· Advise clients on regulatory requirements applicable to imported cosmetic products.
· Support coordination with Korean responsible cosmetic sellers, customized cosmetics sellers, importers, distributors, and other local entities.
· Review responsibilities and documentation required among foreign manufacturers, importers, responsible sellers, and local partners.
· Assist with documentation needed for customs clearance or product release when included in the project scope.
· Support GRP in evaluating prospective local representatives, laboratories, vendors, and business partners.
· Participate in communications with Korean authorities and local stakeholders when authorized by GRP.
Product Safety and Quality Compliance
· Review available safety and quality documentation for cosmetic products.
· Advise on applicable testing, specifications, microbiological quality, stability, safety substantiation, and supporting evidence.
· Assess whether technical documentation adequately supports the product’s intended use and claims.
· Support the evaluation of product complaints, quality issues, undesirable effects, and potential regulatory-reporting obligations.
· Assist with corrective actions, product withdrawals, recalls, safety communications, or regulatory responses when required.
· Ensure that regulatory recommendations prioritize consumer safety, product quality, and legal compliance.
4. REQUIRED QUALIFICATIONS
• Licensed Pharmacist preferred.
Bachelor’s degree in pharmacy, chemistry, cosmetic science, biology, life sciences, regulatory affairs, or a related field.
Advanced degree (Master's or PhD).
- Minimum six (6) years of Regulatory Affairs experience supporting pharmaceutical products.
- Minimum three (3) years of Regulatory Affairs experience supporting cosmetic and/or quasi-drug products.
- Experience preparing and managing MFDS submissions.
- Experience supporting product lifecycle management activities.
- Experience working independently and managing multiple projects simultaneously.
• Experience supporting product notifications, regulatory examinations, submissions, or market-compliance activities.
• Ability to interpret regulations and translate them into practical recommendations.
• Native Korean
• Strong professional proficiency in written and spoken English.
• Ability to prepare clear, accurate, and well-organized regulatory documents in English.
• Ability to work independently and meet established deadlines.
• Strong attention to detail and ability to manage multiple projects.
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5. CORE COMPETENCIES
· Korean Drug, cosmetics and Quasidrugs regulatory expertise
· Regulatory research and interpretation
· Technical document preparation
· Strong analytical and problem-solving abilities
· Effective project and time management
· Clear written and verbal communication
· Client-focused service
· Accuracy and attention to detail
· Cultural awareness and global collaboration
6. EXPECTATION
The contractor is expected to:
· Complete assigned work according to agreed scope, timelines, and quality requirements.
· Provide accurate and current regulatory advice.
· Respond promptly to GRP communications and client requests.
· Notify the GRP project manager immediately of significant risks, delays, or compliance concerns.
· Maintain organized and traceable project records.
· Participate in scheduled meetings across international time zones when reasonably required.
· Submit invoices and activity reports according to the applicable consulting agreement.
· Obtain GRP authorization before performing work outside the approved scope or budget.
· Avoid making commitments to clients or authorities without appropriate GRP authorization.
· Comply with GRP policies, project procedures, confidentiality obligations, and contractual requirements.
7. CONFIDENTIALITY AND CONFLICT OF INTEREST
The contractor must protect all confidential, proprietary, personal, technical, regulatory, and commercial information received from GRP or its clients.
The contractor must disclose any actual or potential conflict of interest before accepting an assignment and must not use or disclose confidential information belonging to another employer, client, or third party.
8. EMPOYMENT TYPE
The candidate should possess knowledge of:
- MFDS regulatory requirements
- Korean pharmaceutical regulations
- Cosmetic regulations
- Quasi-drug regulations
- CTD and eCTD submissions
- GMP requirements
- GDP requirements
- GVP requirements
- Product lifecycle management
- Regulatory intelligence activities
Full-Time Contractor (6-Month Contract-to-Hire)
This position is initially offered as a full-time contractor role for a six (6) month probationary period. During this period, the candidate will be evaluated based on performance, technical competency, quality of work, communication skills, responsiveness, professionalism, and overall fit within the organization.
Candidates who successfully meet performance expectations and business requirements may be offered a permanent full-time employee position at the conclusion of the probationary period, subject to management approval and organizational needs.
COMPENSATION
Full-Time Contractor Period
- Competitive monthly contractor compensation.
- Contractor fee commensurate with qualifications and experience.
- Typical range: KRW 8,000,000 to KRW 11,000,000 per month.
Upon Conversion to Full-Time Employment
- Competitive annual salary package.
- Performance-based bonus opportunities (where applicable).
- Company-sponsored benefits in accordance with local policy.
- Career development and advancement opportunities.
EMPLOYMENT LOCATION
South Korea (Hybrid Work Arrangement)
This position may be performed under a hybrid work arrangement that includes both remote and on-site work. The work location and attendance requirements will be determined based on business needs, client requirements, project assignments, and the discretion of senior management.
The employee may be required to attend:
- Client meetings
- Internal team meetings
- Regulatory authority meetings and inspections
- Training sessions
- Company events and business activities as required
Work arrangement requirements may be adjusted at any time based on operational and business needs.