ICON Strategic Solutions Hiring Regulatory Affairs Specialist | Remote Flexibility
- ICON Strategic Solutions Hiring Regulatory Affairs Specialist – CT/IND, MAA & Lifecycle Submissions | Seoul | Remote Flexibility
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility / Qualifications
- Educational Qualification
- Experience
- Required Skills
- Location & Work Model
- Benefits & Work Culture
- Application Process
- Frequently Asked Questions (FAQs)
- 1. What experience is required for this role?
- 2. Is CT/IND submission experience mandatory?
- 3. Is this a fully remote role?
- 4. Is labeling experience necessary?
- 5. What career growth opportunities are available?
- Recruitment Summary
ICON Strategic Solutions Hiring Regulatory Affairs Specialist – CT/IND, MAA & Lifecycle Submissions | Seoul | Remote Flexibility
ICON Strategic Solutions is currently hiring a Regulatory Affairs Specialist for its Drug / Device Regulatory Affairs division in Seoul, South Korea. This is a remote-enabled opportunity designed for professionals with 2–3 years of experience in pharmaceutical or biotechnology regulatory affairs.
The role focuses on regulatory submissions, lifecycle management, CT/IND filings, MAA/NA applications, safety reporting documentation, and labeling compliance. If you are a regulatory professional looking to work on global submissions while contributing to innovative clinical development programs, this position offers strong international exposure within a world-leading clinical research organization.
Company Overview
ICON plc is a globally recognized healthcare intelligence and clinical research organization (CRO) supporting pharmaceutical, biotechnology, and medical device companies worldwide. The organization provides full-service clinical development, regulatory consulting, clinical trial management, and drug development support across multiple therapeutic areas.
With a strong global footprint, ICON partners with sponsors to accelerate regulatory approvals, optimize submission strategies, and maintain compliance with international health authorities. The company is known for combining scientific expertise with advanced regulatory operations to bring innovative therapies to patients faster.
ICON Strategic Solutions operates as a dedicated regulatory and functional services partner, offering high-level regulatory expertise embedded within sponsor organizations.
Job Role & Responsibilities
The Regulatory Affairs Specialist will support global and regional regulatory submissions across pharmaceutical, biotechnology, and biologics projects.
Key Responsibilities
- Contribute to preparation, compilation, and submission of regulatory documentation including CT/IND applications, MAA/NA filings, lifecycle variations, renewals, DSUR, and PSUR submissions.
- Support regulatory submission planning and execution in collaboration with cross-functional teams.
- Manage label review activities, translation requirements, and fee calculations associated with submissions.
- Review IMPD, Investigator’s Brochure (IB), and core clinical documentation.
- Participate in regulatory intelligence activities to monitor evolving health authority requirements.
- Assist in readability testing and compliance verification for labeling and submission documents.
- Collaborate with regulatory submissions teams, clinical operations, and project stakeholders.
- Contribute to business development initiatives when required.
This position requires hands-on regulatory documentation expertise and strong familiarity with global submission processes.
Eligibility / Qualifications
Educational Qualification
Bachelor’s degree in a scientific or healthcare-related discipline. Advanced degree preferred.
Relevant Courses: B.Pharm, M.Pharm, Pharm.D, BSc Life Sciences, MSc Life Sciences, Biotechnology, Regulatory Affairs, Pharmaceutical Sciences, Biomedical Sciences, Clinical Research, Biochemistry.
Experience
- 2–3 years of regulatory affairs experience in pharmaceutical, biotechnology, or biologics industry.
- Direct exposure to CT/IND, MAA/NA, variations, renewals, DSUR, and PSUR submissions.
Required Skills
- Strong understanding of global regulatory submission requirements.
- Familiarity with lifecycle management and post-approval variation procedures.
- Knowledge of labeling compliance, translation management, and regulatory intelligence.
- Excellent written and verbal communication skills.
- High attention to detail and ability to manage multiple regulatory timelines.
- Ability to work independently in a remote or hybrid environment.
Professionals with experience handling biologics submissions or complex multinational filings will have an added advantage.
Location & Work Model
Location: Seoul, South Korea
Work Model: Partial Home-Based / Remote
Department: Drug / Device Regulatory Affairs
Requisition ID: JR145536
Salary details are not publicly disclosed. ICON offers competitive compensation aligned with industry standards for regulatory affairs specialists in the clinical research and pharmaceutical sectors.
Benefits & Work Culture
ICON fosters a performance-driven and inclusive work environment. Employees benefit from:
- Competitive salary packages.
- Health insurance coverage options.
- Retirement planning programs.
- Global Employee Assistance Programs.
- Work-life balance and flexible working arrangements.
- Equal opportunity and inclusive workplace policies.
The organization promotes continuous learning and professional growth within regulatory science and clinical development.
Application Process
Interested candidates can apply directly through the official ICON careers portal:
Ensure your resume highlights regulatory submission experience, lifecycle management exposure, and global regulatory documentation handling.
Frequently Asked Questions (FAQs)
1. What experience is required for this role?
Candidates must have 2–3 years of regulatory affairs experience in pharmaceutical or biotechnology sectors.
2. Is CT/IND submission experience mandatory?
Yes. Hands-on experience with CT/IND, MAA/NA, variations, and safety submissions is required.
3. Is this a fully remote role?
The role is partially home-based with remote flexibility.
4. Is labeling experience necessary?
Yes. Label review and translation management experience is part of the responsibilities.
5. What career growth opportunities are available?
Professionals can progress into Senior Regulatory Specialist, Regulatory Manager, or Global Regulatory Strategy Lead roles.
Recruitment Summary
| Company | ICON Strategic Solutions |
|---|---|
| Vacancies | Regulatory Affairs Specialist |
| Required Education | Bachelor’s in Life Sciences / Pharmacy (Advanced Degree Preferred) |
| Experience | 2–3 Years in Pharmaceutical / Biotechnology Regulatory Affairs |
To apply for this job please visit careers.iconplc.com.
