341719BR
Jun 16, 2022
Singapore

Job Description

Novartis has a very rich innovative pipeline with no shortage of new drug applications for submission. In addition, as part of the management team, the RA manager will be given opportunities to take the lead in registering new therapeutics in the cell and gene therapy space. This is Novartis' unique value proposition and sets us apart vs the rest of the pharma industry
This role is part of the RA management team within the RA department of Novartis Singapore and is a visible partner to the commercial team. There is a strong focus on building a cohesive and supportive team culture which is one key focus area of the RA management team. We often partner with external stakeholders on projects that create value whilst at the same time further the reputation for Novartis
Your responsibilities include, but are not limited to:
• Responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
• Partners with regions to align on regulatory strategy in order to fulfil business objectives -Implements RFP across assigned regions.
• Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
• Develops and implements plans for timely response to HA requests and coordinates responses.
• May serve as local HA liaison depending on location (e.g., FDA or EMA).
• Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
• Review of global dossier summary documents.
• Develops and implements plans to avoid/minimize clock stops during submission review.
• Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).

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:
• A minimum of Bachelor’s degree in health-related science, life science, Pharmacy degree desired.
• 4-5 years of experience in regulatory affairs or related work
• Proven experience track record of preparing and reviewing regulatory documentation, and managing submissions successfully.
• Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of therapeutic products.
• Good understanding of local regulatory environment, guidelines and processes for product registration. Ability to apply knowledge to general regulatory topics for projects assigned.
• Computer literacy with knowledge of MS Office applications. Good interpersonal, organizational, negotiation and problem solving skills Excellent verbal and written communication skills.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!
Global Drug Development
REG AFFAIRS GDD
Singapore
Singapore
Research & Development
Full Time
Regular
No
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341719BR

RA Manager, GDD

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