347403BR
Jun 21, 2022
Philippines

Job Description

200+ projects in development. And that’s just in 2018. This is your chance to help reimagine medicine in 2022. Novartis is looking for a dedicated individual to join the Philippine Regulatory Affairs team. Take the first step by looking at our track record of amazing accomplishments on behalf of our patients. Novartis employees have enjoyed long, rewarding careers working with colleagues around the world. Read on for details about the role and how you can join a world-class organization.

The Regulatory Affairs Specialist contribute and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. You will also support all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.


Your Responsibilities:
Your responsibilities include, but not limited to:

• Set registration plan, perform product registration in accordance with registration and launch plan, & maintain product license with local regulation and global compliance strategy
• Review new projects and set development plan (timeline etc.) in collaboration with Global DRA and related functions
• Achieve the best product registration with commercially attractive labelling in accordance with registration plan
• Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance
• Perform IND application & get approval to ensure study timeline in collaboration with medical team and Global DRA
• Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.)
• Foster and maintain good relations with internal and external stakeholders
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Degree in Pharmacy (Must be licensed)
• 1 year of experience in Regulatory Affairs and dealing with FDA
• In depth knowledge of the Pharma value chain and environment, healthcare services and communications field
• Excellent interpersonal communication and influencing skills; Excellent presentation skills

Why Novartis?
769 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
REG AFFAIRS GDD
Philippines
Metro Manila
Research & Development
Full Time
Regular
No
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347403BR

Regulatory Affairs Specialist

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