Specialist, Regulatory Affairs(계약직)

2+ years

Not Disclosed

Seoul

10 Nov. 24, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Regulatory Affairs Specialist

Organization: Organon
Location: South Korea
Employment Type: Temporary (Minimum 18-month contract, with potential extension based on business needs)

Position Overview

The Regulatory Affairs Specialist plays a critical role in ensuring the timely registration and life cycle management of new and existing products. This includes preparing regulatory dossiers, managing compliance with local and global policies, and coordinating product registration and updates. The incumbent will also support operational and administrative activities to maintain high standards of regulatory compliance.

Key Responsibilities

Product Registration and Lifecycle Management

New Product and Variation Registration:
- Prepare and submit regulatory dossiers in alignment with the plan.
- Liaise with MFDS, internal headquarters, and subject-matter experts to resolve regulatory queries.
Develop Regulatory Strategies:
- Support the Regulatory Affairs Manager in analyzing product and regulatory information.
- Anticipate potential challenges and devise mitigation plans.
Lifecycle Updates:
- Update safety and CMC (Chemistry, Manufacturing, and Controls) information to meet target dates.
- Maintain compliance with global RA databases and follow up on post-approval activities, including RMP, DMF, annual reports, and renewals.

Regulatory Operations

Operational Support:
- Provide administrative assistance for regulatory filings, including:
  - Supporting electronic submissions via the MFDS portal.
  - Managing internal e-archiving systems and dossier publishing systems.
Artwork and Compliance:
- Assist in developing and reviewing artwork for compliance with regulatory standards.
- Verify current artwork in use and ensure compliance with global policies and regulatory intelligence.
Database and Metrics Management:
- Monitor and update the RA database with timely and accurate information.
- Track regulatory compliance metrics such as SLU, regulation impact assessments, artwork, and training.

Administrative Support

Official Correspondence:
- Handle inbound and outbound official communications.
- Manage KPIC product image registration and KPIS barcode registration.
Licensing and Customs Clearance:
- Facilitate the clearance of registration samples/reagents.
- Ensure business and product license maintenance through timely submissions.

Must-Have Qualifications

Minimum of 2 years of experience in Regulatory Affairs (RA).
Strong organizational and analytical skills to handle complex regulatory requirements.

Good-to-Have Qualifications

Pharmacist license.
Experience in Quality Assurance (QA) or Quality Control (QC), especially in laboratory settings.
Excellent communication skills to interact with cross-functional teams and external authorities.

Additional Notes

This position is a maternity leave backup role with a minimum 18-month fixed term. The contract may be extended based on business requirements.

About Organon

Organon is a global healthcare leader, delivering innovative solutions that empower people to live healthier lives. With a strong focus on women’s health, biosimilars, and a trusted portfolio of health solutions, Organon is committed to addressing unmet healthcare needs globally.

Organon is an equal opportunity employer, fostering an inclusive environment for candidates from diverse backgrounds.

For more details about Organon's commitment to diversity and equal opportunity, please visit our careers page.

Employee Status: Temporary (Fixed Term)
Relocation: Domestic
Flexible Work Arrangements: Available
Number of Openings: 1

Requisition ID: R529092

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