The Role
Manages pharmaceutical product registrations, regulatory submissions, approvals, licensing, variations, renewals, safety communications, and post-approval activities. Develops registration strategies, supports clinical trial approvals and product launches, maintains regulatory databases, monitors compliance with pharmaceutical regulations and industry codes, and coordinates with health authorities and cross-functional stakeholders. Also supports adverse event and technical complaint reporting.
Summary Generated by Built In
Job Description Summary
The RA specialist sets registration plan and perform product registration in accordance with registration and launch plan, and maintain product license with local regulation and global compliance strategy.
Job Description
Major accountabilities:
Major accountabilities
- Review pipeline and set the registration strategy in collaboration with global RA and related CPO functions with support from senior specialist and manager
- Achieve the best product registration with optimal label by conducting research on submission requirements and approval lead time in accordance with registration plan.
- Support launches (artwork, barcode, Drug ID mark, etc.)
- Perform CTA and get approval to ensure study timeline in collaboration with other CPO functions.
- Support IMP management through confirmation of variant number.
- Maintain product license by managing variations for label, quality (CMC and mfg. site) and administrative changes according to local law/regulation/guidelines, company strategy and global compliance.
- Secure product license by managing Reevaluation/Renewal/Reexamination /HA safety communication
- Ensure post approval activities (website, artwork, etc.)
- Submit RMP by supporting of other function in line with global direction.
- Be accountable for correct and timely update of RA compliance (registration) database (DRAGON)
- Ensure industry compliance with NP4, KRPIA code of conduct
- Support cross functional activities by delivering regulatory input
- Understand basic knowledge on the legal frameworks, internal processes, GxP’s
- Keep abreast of relevant laws /regulations and apply to related CPO activities
- Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis products according to respective SOP
- Foster and maintain good relations with internal and external stakeholders.
- Communicate effectively with HA and other BFs
- Understand RA internal working process and handle own task well
Essential Requirements
- Education: 4-year university degree, preferably in Pharmacy, Biochemistry, Chemistry, Life Sciences, or a related field
- Languages: Fluent in both written and spoken English
- Experience: Pharmaceutical industry experience preferred
- Knowledge: Basic understanding of regulatory affairs, drug development process, and applicable pharmaceutical regulations/guidelines preferred
Skills Desired
Clinical Trials, Collaboration, Detail-Oriented, Project Planning, Regulatory ComplianceSkills Required
- Four-year university degree, preferably in Pharmacy, Biochemistry, Chemistry, Life Sciences, or a related field
- Fluent written and spoken English
- Pharmaceutical industry experience
- Basic understanding of regulatory affairs, the drug development process, and applicable pharmaceutical regulations and guidelines
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
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The Company
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
