-Directs the development of submission of product registration, progress reports, supplements, amendments, and/periodic experience reports. Provides strategic product direction to teams on interaction negotiates evidence with regulatory agencies. Interacts negotiates with regulatory agency personnel inder to expedite approval of pending registration answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid timely approval on of new drugs, biologics/biotechnology and/medical devices continued approved status of marketed drugs medical devices. Serves as regulatory representative to marketing research project teams government regulatory agencies. Provides advice to development and/marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations interpretations. Coordinates, reviews, may prepare reports fsubmission.
Majaccountabilities:
•Is responsible fimplementing regulatory strategy managing operational activities fassigned medium regions. Provides input global regulatory strategy contributes to Regulatory Functional Plan (RFP) Seed Document, their equivalents, including identification of gaps risks in global strategic plan fassigned regions.
•Partners with regions to align on regulatory strategy inder to fulfil business objectives -Implements RFP across assigned regions. Determines requirements sets objectives fHealth Authority (HA) interactions with DRA GPT representative and/GTAL.
•Facilitates preparation finalization of briefing books contributes to preparation of summary documents. Develops implements plans ftimely response to HA requests coordinates responses. May serve as local HA liaison depending on location (e.g., FDA EMA).
•Drives coordination, planning, submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Develops implements plans to avoid/minimize clock stops during submission review. Reviews, approves submits Clinical Trial Applications (CTAs) Investigational New Drugs (INDs). Reviews submits Risk Management Plans.
•May lead negotiations fregional approvals independently with DRA GPT representative and/GTAL. Responsible ffacilitating timely submission approval of dossier with HAs under the guidance of the DRA GPT representative and/GTAL.
•Erroneous decisions result in critical delays modifications to projects operations
cause substantial expenditure of additional time, human resources, funds
jeopardize future business activity -Contributes to often leads the development of departmental goals 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)
Minimum Requirements:
Work Experience:
•Functional Breadth. Cross Cultural Experience. Lifesciences.
•Operations Management Execution.
•Project Management.
•Clinical Trials. Drug Development.
•Detailiented.
•Negotiation Skills.
•Regulatory Compliance.
•English.
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职位要求：
Negotiation Skills
Regulatory Compliance
Detail-Oriented
Drug Development
Clinical Trials
Lifesciences
