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Regulatory Affairs Specialist

2+ years
Not Disclosed
10 July 31, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Summary

Internal Role Title: Regulatory Affairs Specialist
Location: Seoul, Korea #LI-Hybrid
Note: Novartis is unable to offer relocation support for this role; please apply only if you are already based in or can access this location.

About the Role:
The Regulatory Affairs Specialist is responsible for setting and executing registration plans for product registration, ensuring compliance with local regulations and global strategies. This role involves managing product licenses, supporting launches, and maintaining regulatory compliance.

Key Responsibilities

  • Registration Strategy: Review the pipeline and develop registration strategies in collaboration with global Regulatory Affairs (RA) and related functions, with support from senior specialists and managers.
  • Product Registration: Achieve optimal product registration with efficient labeling by researching submission requirements and approval timelines.
  • Launch Support: Assist with product launches, including artwork, barcodes, and Drug ID marks.
  • CTA Management: Perform Clinical Trial Applications (CTA) and ensure timely study approvals. Support Investigational Medicinal Product (IMP) management.
  • License Maintenance: Handle variations for labels, quality (CMC and manufacturing site), and administrative changes. Manage license re-evaluations, renewals, and safety communications.
  • Regulatory Compliance: Submit Risk Management Plans (RMP) and update RA compliance databases. Ensure compliance with industry codes such as NP4 and KRPIA.
  • Cross-Functional Support: Provide regulatory input for cross-functional activities. Stay informed about relevant laws and regulations, applying them to CPO activities.
  • Adverse Events Reporting: Report and follow up on all spontaneous adverse events (AE) and technical complaints according to SOPs.
  • Relationship Management: Foster good relations with internal and external partners. Communicate effectively with Health Authorities (HA) and other business functions.

Essential Requirements

  • Experience: 1-2 years in the pharmaceutical industry, preferably in regulatory affairs, registration, or a related field.
  • Licenses: Korea pharmacist license is preferred.
  • Languages: Proficiency in English (both speaking and writing).
  • Skills: Strong interpersonal skills, project management capabilities, and the ability to work under pressure.

Why Novartis?

At Novartis, our mission is to reimagine medicine to improve and extend lives. We value the contributions of our associates who drive our ambitions forward. Join us to be part of a community that collaborates, supports, and inspires each other to achieve breakthroughs that change patients' lives. Learn more about our mission and culture here.

Benefits and Rewards: Find detailed information about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity & Inclusion: Novartis is an Equal Opportunity Employer committed to a diverse and inclusive workplace. We do not discriminate in employment practices based on race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Join Our Network: If this role isn’t a perfect match for you but you want to stay informed about future opportunities at Novartis, join our Novartis Network.

Division: Development
Business Unit: Innovative Medicines
Location: South Korea
Site: Seoul
Company / Legal Entity: Novartis Korea Limited
Functional Area: Research & Development
Job Type: Full time
Employment Type: Regular
Shift Work: No