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Regulatory Submissions (Study Start-Up) Manager / Associate Director, Regulatory Submissions
Vintnersâ Place , 68 Upper Thames Street Seoul, Seoul N/a US
Job Description
Job Title: Regulatory Submissions (Study Start-Up) Manager / Associate Director
Location: Seoul, South Korea
Function: Regulatory Submissions / Study Start-Up
Role Overview
A global clinical research organisation is seeking a Regulatory Submissions professional in South Korea, with flexibility to appoint at either Manager or Associate Director level depending on experience and seniority.
This role sits within the Study Start-Up / Regulatory Submissions function and is responsible for leading regulatory submission activities across South Korea, with regional exposure across the APAC region. The position is primarily project-management focused, with limited immediate line management responsibilities and potential for future leadership growth.
Role Level Flexibility
This is one headcount with flexibility on seniority. The organisation is open to:
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Regulatory Submissions Manager profiles with strong hands-on submission and start-up experience, or
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Associate Director profiles with broader regional exposure and regulatory leadership experience
Final title, scope, and compensation will be determined based on experience and overall fit.
Key Responsibilities (Both Levels)
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Lead and manage regulatory submissions for clinical trials, with a strong focus on study start-up activities
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Act as the primary regulatory liaison with the local health authority in South Korea
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Coordinate submissions locally and support regional (APAC) regulatory activities
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Partner closely with internal stakeholders and external sponsors to ensure timely, compliant submissions
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Provide regulatory guidance across multiple projects and contribute to process optimisation and best practices
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Support inspection readiness and regulatory strategy initiatives as required
Mandatory Requirements – Manager Level
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Bachelor’s degree in a science-related discipline
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Minimum 5 years’ experience within a CRO or similar environment
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Hands-on experience managing regulatory submissions in South Korea, with some exposure to APAC regions
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Strong English communication skills (written and verbal) for interaction with global stakeholders and health authorities
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Seoul-based and open to the organisation’s working arrangement:
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Initial period fully office-based
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Transition to a hybrid model thereafter
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Line management experience is an advantage, though the role is primarily project-focused
Mandatory Requirements – Associate Director Level
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Bachelor’s degree in a science-related discipline
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Minimum 8 years’ experience within a CRO or equivalent regulated environment
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Strong regulatory submissions experience across South Korea with broader APAC exposure
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Excellent English communication skills (written and verbal)
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Seoul-based and open to the organisation’s working arrangement:
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Initial period fully office-based
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Transition to a hybrid model thereafter
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Prior people-leadership experience is desirable; the role remains project-led initially with scope to expand
Compensation & Benefits
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Competitive annual base salary aligned to seniority and experience
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Daily commuting allowance for in-office attendance
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Annual meal or lunch allowance
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Full benefits package aligned with local market standards
Additional Information
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This is a single position with flexible seniority, not multiple openings
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The role offers strong regional exposure across APAC and long-term growth potential within regulatory leadership
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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