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Global Program Regulatory Manager-LCM
Novartis
posted 1d ago
Job Description
- Regulatory Strategy -Responsible for implementing regulatory strategy and managing operational activities for assigned 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
- HA Interactions-Determines requirements and sets objectives for Health Authority (HA) interactions with RA 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.Leads HA meetings independently or with RA GPT representative and/or GTAL as appropriate.May serve as local HA liaison depending on location (e.g., FDA or EMA).
- Submissions and Approvals -Implements strategy across regions in line with global strategy.Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.Proposes options to minimize risk.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.
- Prescribing Information- Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.Generates local PIs, ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive.
- Identifies potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.Revises label as needed to achieve timely HA approval with best possible label based on data available.
- Regional Excellence and Compliance - Responsible for finalization and on time submission of annual reports and renewals across assigned regions.Responsible for appropriate entering and quality of product specific attributes in compliance database.
- Promotional/Non-promotional Review - Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with Novartis policies and guidelines.
- Leadership/Managerial -Provides strategic input and guidance to the MA submissions coordinator and Canada team. Management of approx. 8-12 direct reports . Recruits talents, manages performance (set objectives, review performance and plan compensation), develops associates (development/training plans, Organizational Talent Review, coaching and mentoring)
- Strong knowledge of regulatory submisson and approval processes in 1 or more major regions.
- Experience leading regulatory submissions and approvals in at least 1 major region.
- Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry
- Experience in HA negotiations. Experience or project allocation/project planning for a team
- Strong interpersonal, communication, negotiation and problem-solving skills. Organizational awareness (e.g., interrelationship of departments, business priorities).
- Fluency in English as a business language. Excellent written and verbal communication skills.
- Confident, articulate, and professional speaking abilities (and experience). Empathic listener and persuasive speaker. Excellent presentation and negotiation skills
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
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