Regulatory Affairs Manager South Korea

JOB DESCRIPTION FOR REGULATORY AFFAIRS MANAGER –SOUTH KOREA

1. GENERAL REQUIREMENTS

Global Regulatory Partners (GRP) is seeking an experienced Regulatory Affairs Manager – South Korea to lead and manage regulatory activities for pharmaceutical products, biologics, orphan drugs, and new product registrations in South Korea.

The successful candidate will serve as the primary regulatory contact for South Korea and will be responsible for developing and executing regulatory strategies, managing regulatory submissions and health authority interactions, and providing regulatory guidance to GRP clients and internal teams throughout the product lifecycle.

The Regulatory Affairs Manager will oversee new product registrations, regulatory submissions, responses to health authority questions, post-approval variations and maintenance activities, labeling and regulatory compliance, while ensuring that projects are delivered accurately and within established timelines.

The position requires direct interaction with the Ministry of Food and Drug Safety (MFDS), as well as close collaboration with GRP clients, local partners, and cross-functional teams. The Regulatory Affairs Manager is expected to proactively identify regulatory risks, provide practical recommendations, communicate regulatory developments, and ensure compliance with applicable Korean regulatory requirements and GRP quality standards.

2. RESPONSIBILITIES

1. Regulatory Strategy & Client Leadership

• Serve as the primary regulatory contact for South Korea.
• Develop and execute Korea regulatory strategies for assigned products.
• Advise clients on Korean regulatory requirements and proposed pathways.
• Translate MFDS requirements into practical recommendations and project plans.

2. MFDS Submissions & Health Authority Management

• Prepare, review, compile, and submit regulatory dossiers to MFDS.
• Manage new applications, amendments, variations, renewals, and lifecycle submissions.
• Coordinate responses to MFDS questions, deficiency letters, and regulatory requests.
• Liaise directly with MFDS regarding applications, approvals, and regulatory inquiries.
• Organize and manage consulation meeting with MFDS.

3. Product Lifecycle & Compliance

• Maintain regulatory compliance throughout the product lifecycle.
• Review labeling, product information, packaging, claims, and promotional materials for regulatory compliance.
• Maintain submission trackers, regulatory databases, regulatory procedures, work instructions, and templates.
• Support audit and inspection readiness.

4. Regulatory Intelligence

• Monitor changes in Korean pharmaceutical, cosmetic, and quasi-drug regulations.
• Assess the potential impact of new requirements on GRP clients and their products.
• Communicate important regulatory changes and recommend appropriate actions.

5. Cross-Functional & Project Management

• Coordinate with Quality Assurance, Pharmacovigilance, Medical Affairs, Clinical Operations, Supply Chain, Manufacturing, Business Development, and Project Management.
• Ensure Korean regulatory requirements are incorporated into development, registration, launch, and lifecycle plans.
• Manage multiple regulatory projects, priorities, timelines, and client deliverables.

6. Local Partners & Vendors

• Support GRP in evaluating Korean laboratories, regulatory vendors, local representatives, and other partners.
• Coordinate regulatory activities with importers, distributors, responsible sellers, and other relevant local entities.
• Participate in communications with Korean authorities and stakeholders as authorized by GRP.

7. Regulatory Leadership and Management

Lead and coordinate regulatory activities for South Korea, ensuring high-quality and timely execution of client projects. Provide regulatory oversight and guidance to local consultants, partners, and project team members; manage priorities and deliverables; escalate significant regulatory risks; and support the continued development of GRP’s regulatory capabilities in South Korea.

3. QUALIFICATIONS

Education

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Life Sciences, Regulatory Affairs, or a related field.
• Licensed Pharmacist preferred.
• Advanced degree (Master’s or PhD) preferred.

Regulatory Affairs Experience

• Minimum six (6) years of Regulatory Affairs experience in the pharmaceutical industry.
• Demonstrated experience with new product registrations, including experience supporting orphan drugs and/or innovative pharmaceutical products.
• Hands-on experience in preparing, reviewing, and managing MFDS regulatory submissions.
• Experience managing product registration, regulatory review/examinations, health authority queries, and post-approval lifecycle activities.
• Experience supporting regulatory compliance and maintenance of approved products.
• Ability to work independently and manage multiple regulatory projects and priorities simultaneously.

Languages & Professional Skills

• Native-level Korean language proficiency.
• Strong professional proficiency in written and spoken English.
• Ability to prepare clear, accurate, and well-organized regulatory documents in English.
• Strong attention to detail with the ability to meet established timelines and deadlines.
• Strong organizational, communication, and project-management skills.

4. CORE COMPETENCIES

· Korean pharmaceutical, orphan drug and new registration regulatory expertise

· Exoerinece in managing Intercation with MFDS and organizing consulation meetings with MFDS and other Health authorities if needed .

· Registrayion dossier prepration and submission to MFDS 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

5. EXPECTATION

The Regulatory Affairs Manager – South Korea is expected to:

· Take ownership of assigned regulatory projects and ensure activities are completed accurately, efficiently, and within agreed timelines.

· Maintain a high standard of regulatory quality, ensuring submissions, responses, and other deliverables are complete, accurate, and compliant with applicable Korean requirements.

· Communicate proactively with GRP management, clients, project teams, and local stakeholders regarding project status, regulatory issues, risks, and required actions.

· Identify and escalate regulatory risks or significant issues promptly, together with practical recommendations for resolution.

· Maintain professional and effective interactions with MFDS and other relevant Korean authorities, when authorized.

· Provide practical, solution-oriented regulatory advice to support client objectives while maintaining regulatory compliance.

· Manage multiple projects and priorities independently, meeting agreed milestones and deadlines.

· Maintain accurate project documentation, regulatory records, trackers, and correspondence in accordance with GRP requirements.

· Collaborate effectively with GRP global and local teams and support cross-functional activities as required.

· Maintain strict confidentiality of client, product, regulatory, and GRP information.

· Comply with GRP policies, project procedures, confidentiality obligations, quality requirements, and contractual commitments.

· Demonstrate professionalism, accountability, integrity, and sound regulatory judgment in all client and regulatory interactions.

6. 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.

7. EMPOYMENT TYPE

The candidate should possess knowledge of:

• MFDS regulatory requirements
• Korean pharmaceutical regulations
• CTD and eCTD submissions
• GMP 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.

8. COMPENSATION

Full-Time Contractor Period

• Competitive monthly contractor compensation.
• Contractor fee commensurate with qualifications and experience.
• Typical range: KRW 11,000,000 to KRW 13,000,000 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.

9. 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.