Regulatory Affairs AD

Key Responsibilities：

• 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). Reviews and submits Risk Management Plans.

• May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL. Contributes to and often leads the development of departmental goals and objectives.

• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.

• Distribution of marketing samples (where applicable)

Commitment to Diversity and Inclusion / EEO:

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

Essential Requirements:

• At least 10 years in RA and/or drug/biologic;

• The experience in filing global trial CTA independently;

• The experience in filing and obtaining NDA approval;

• The experience in various types of regulatory submission/approvals;

Desirable Requirements:

• Bachelor or above with Pharmaceutical/Medical background;

• Fluency in English and Chinese  (oral and written).

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:  https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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