Manager, Regulatory Affairs

Career Category

Regulatory

Job Description

Job Summary

Clinical trial activities are growing rapidly and dynamically, and we are currently seeking a full-time, Clinical Trials Regulatory Submissions Manager to join our Local Regulatory in Amgen Korea. This position plays a key role in the clinical trial application management, import licenses and regulatory agency inspections at Amgen.

The Clinical Trials Regulatory Submission Manager is responsible for the overall submission strategy definition including interactions with Health Authority, compiling submission dossier, execution and management of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy.

This position interacts directly with International Regulatory Team, CMC Global Product Leads, Clinical Project Management (Local Trial Managers) etc. and collaborates with Regional and Global Study Operations (GSO) teams, Pharmacovigilance, Clinical Supply Chain, Global Study Operations and Functional Service Providers to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements.

Responsibilities Summary

• Efficiently end-to-end manages Clinical Trials Regulatory submission in Korea for new and ongoing project(s) or programs, including and not limited to initial applications, clinical protocol amendments, ICF amendments, quality (CMC) amendments, study periodic reporting, until the project is officially closed.

• Develops, with the input of importer of record, study specific import licenses approvals and keeps it updated.

• Monitors efficiency, quality and adherence to project timelines, SOPs and local regulations.

• Attends to regulatory inspections and corporate audits, representing the RA function.

• Communicates overall regulatory status to internal teams and service providers.

• Attends to project meetings with cross functional department leads to provide strategy, timelines and requirements for regulatory submissions and approvals.

• Works with internal team members to establish and clarify regulatory requirements

• Responsible for clinical trial regulatory intelligence, including regular updates to databases.

• Coordinate with local and global team CTA pre-submission meetings with Agency, if needed.

• Where applicable, provides work instructions to related team members in preparation of regulatory submissions, timeline estimations, issues resolution, etc.

• Collaborate with the regional or local study team (e.g. Start-up Associates, Project Managers, Regulatory Affairs, Vendors, and Contracts Department) during the total duration of study, closely monitoring to ensure regulatory milestones are met.

• Escalates issues to leadership, including plans for addressing/mitigating risks/gaps.

• Work with and oversight the in-country Functional Service Provider (FSP), ensuring that the FSP delivers per contract as well as the timelines and quality of all regulatory and safety filings.

Minimum Qualifications

• Bachelor’s in Pharmacy or equivalent in a health-related field plus 6-7 years of clinical trials experience

o within the total years of experience, at least 3-4 years of regulatory submissions experience is required

o Strong technical knowledge and 3-4 years of experience in executing Clinical Trial Applications in Korea

o (preferred) Experience in preparing, attending and responding to GCP Inspection

Knowledge and Soft Skills

• Good written and verbal communication skills in English;

• Degree and in-depth regulatory experience and/or related to the country.

• Depth knowledge of country legislation and regulations relating to medicinal products.

• Ability to conceptualize, develop and manage timelines, including its updates;

• Ability to delegate and make decisions, including risk-based ones;

• Ability to manage multiple projects and priorities;

• Ability to develop and maintain productive relationships with coworkers, managers and

service providers.

• Ability to work independently and asynchronously with different time zones within a

matrixial project team environment.

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